Morbid Obesity Clinical Trial
Official title:
Single Minute of Positive End Expiratory Pressure at the Time of Induction: Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
Verified date | January 2017 |
Source | Sri Aurobindo Institute of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Positive end expiratory pressure (PEEP) at the time of induction increases
oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all
cases. Factors affecting the action of PEEP have not been elucidated well and remain
controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been
proven in previous studies. Thus this study was planned to evaluate the action of PEEP on
the basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily
measured by trans-thoracic echocardiography.
Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA
grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic
bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated
in the study. Thirty patients received no PEEP at the time of induction while other 30
patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at
the time of intubation, 5 min after intubation and 10 min after intubation. Patients were
then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP
or > 30 mm Hg
Status | Completed |
Enrollment | 70 |
Est. completion date | August 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: Patients recruited were - Anesthesia society of Anesthesiologist (ASA) physical status l, II or III, - Aged 20-65 years - BMI > 40kg/m2 - scheduled for elective laparoscopic bariatric surgery Exclusion Criteria: - Patients who denied consent - Did not fulfill the inclusion criteria, - patients undergoing Emergency and/or open surgery - Patients requiring more than 2 attempts for intubation |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sri Aurobindo Institute of Medical Sciences |
Almarakbi WA, Fawzi HM, Alhashemi JA. Effects of four intraoperative ventilatory strategies on respiratory compliance and gas exchange during laparoscopic gastric banding in obese patients. Br J Anaesth. 2009 Jun;102(6):862-8. doi: 10.1093/bja/aep084. — View Citation
Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. — View Citation
Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. — View Citation
Fougères E, Teboul JL, Richard C, Osman D, Chemla D, Monnet X. Hemodynamic impact of a positive end-expiratory pressure setting in acute respiratory distress syndrome: importance of the volume status. Crit Care Med. 2010 Mar;38(3):802-7. doi: 10.1097/CCM. — View Citation
Gattinoni L, Pesenti A, Baglioni S, Vitale G, Rivolta M, Pelosi P. Inflammatory pulmonary edema and positive end-expiratory pressure: correlations between imaging and physiologic studies. J Thorac Imaging. 1988 Jul;3(3):59-64. Review. — View Citation
Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, Fumagalli R, Marcolin R, Mascheroni D, et al. Relationships between lung computed tomographic density, gas exchange, and PEEP in acute respiratory failure. Anesthesiology. 1988 De — View Citation
Luecke T, Roth H, Joachim A, Herrmann P, Deventer B, Weisser G, Pelosi P, Quintel M. Effects of end-inspiratory and end-expiratory pressures on alveolar recruitment and derecruitment in saline-washout-induced lung injury -- a computed tomography study. Ac — View Citation
Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Cri — View Citation
McQuillan BM, Picard MH, Leavitt M, Weyman AE. Clinical correlates and reference intervals for pulmonary artery systolic pressure among echocardiographically normal subjects. Circulation. 2001 Dec 4;104(23):2797-802. — View Citation
Pelosi P, Croci M, Ravagnan I, Cerisara M, Vicardi P, Lissoni A, Gattinoni L. Respiratory system mechanics in sedated, paralyzed, morbidly obese patients. J Appl Physiol (1985). 1997 Mar;82(3):811-8. — View Citation
Pelosi P, Goldner M, McKibben A, Adams A, Eccher G, Caironi P, Losappio S, Gattinoni L, Marini JJ. Recruitment and derecruitment during acute respiratory failure: an experimental study. Am J Respir Crit Care Med. 2001 Jul 1;164(1):122-30. — View Citation
Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Fredén F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater | Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia | Arterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater | Arterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline value | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia | Pulse Rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater | Pulse Rate (beats/ min) was recorded from ABG preoperatively and taken as baseline value | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia | Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater | Systolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia | Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater | Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube | Arterial oxygenation (PaO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube | Arterial carbon di oxide (PaCO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube | Pulse rate (beats/ min) was recorded just after the placement and cuff inflation of endotracheal tube | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube | Systolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube | Diastolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation | Arterial oxygenation (PaO2) in mm Hg was recorded five minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation | Arterial carbon di oxide (PaCO2) in mm Hg was recorded five minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation | Pulse rate (beats/ min) was recorded five minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation | Systolic BP in mm Hg was recorded five minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation | Diastolic BP in mm Hg was recorded five minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation | Arterial oxygenation (PaO2) in mm Hg was recorded ten minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation | Arterial carbon di oxide (PaCO2) in mm Hg was recorded ten minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation | pulse Rate (beats/ min) was recorded ten minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation | Systolic BP in mm Hg was recorded ten minutes post intubation | |
Primary | effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction | Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation | Diastolic BP in mm Hg was recorded ten minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Preoperative arterial oxygenation was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Preoperative arterial carbon di oxide was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Preoperative pulse rate was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Systolic blood pressure was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Diastolic blood pressure was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Arterial oxygenation recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Arterial carbon di oxide (mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Pulse rate (beats/ min) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameters was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Systolic pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Diastolic blood pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Arterial oxygenation recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded five minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Arterial carbon di oxide (mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded five minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Pulse rate (beats/ min) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded five minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Systolic pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded five minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Diastolic blood pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded five minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Arterial oxygenation (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded ten minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Arterial carbon di oxide (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded ten minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Pulse rate (beats/ min) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded ten minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Systolic blood pressure (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded ten minutes post intubation | |
Secondary | Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters | Diastolic blood pressure(mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP = 30 mm Hg with those patients who did not receive PEEP and had PASP = 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP | ABG and hemodynamic parameters were recorded ten minutes post intubation |
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