Bariatric Surgery Clinical Trial
Official title:
Does Pulmonary Compliance Optimization Through PEEP Manipulations Reduces the Incidence of Postoperative Hypoxaemia in Bariatric Surgery?
Verified date | January 2018 |
Source | Brugmann University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
General anesthesia, even in patients in good health, impairs gas exchanges and ventilatory
mechanics. These effects result primarily from atelectasis formation. They occur in 85-90% of
healthy patients in the minutes following the induction when a positive end expiratory
pressure (PEEP) is not used.
The functional residual capacity (FRC) of obese patients during general anesthesia is even
smaller than the one of healthy patients. There is a direct relationship between the body
mass index and the decrease of the functional residual capacity. Obese patients have
therefore more atelectasis. The increased abdominal pressure during the pneumoperitoneum will
increase the decrease of the CRF, and thus aggravate the formation of these atelectasis.
Atelectasis affect the peroperative gas exchanges and are likely to be involved in the
worsening of postoperative hypoxemia episodes. In addition, atelectasis alter the clearance
of secretions and the lymph flow, which predispose to lung infections.Taking all these
factors into account, it is logical to think that the atelectasis presence can lead to an
increase of the postsurgical morbidity (respiratory distress, infections). That is why
actively fighting against the formation of these atelectasis is important.
There is a lack of scientific evidence to say that the strategies against atelectasis as PEEP
have a significant impact on the patient's postoperative status. The expected clinical
benefits balance (reduction of respiratory distress episodes, infections and mortality)
versus the risks linked to the maneuvers done to reduce the development of atelectasis
(barotraumas, cardiac complications) remains to be determined.
The primary goal of this study is to evaluate the impact of two different alveolar
recruitment strategies on the incidence of postoperative hypoxemia in obese patients after
bariatric surgery.
The secondary objectives of this study are to compare the number of recruitment maneuvers,
the Pa02 / FI02 ratio (ratio of arterial oxygen partial pressure to fractional inspired
oxygen), the dynamic compliance, the anatomic dead space and intraoperative PaCO2-EtCO2
gradient (arterial and end tidal gradient) between two alveolar recruitment strategies
applied in obese patients during laparoscopic bariatric surgery (gastric bypass or sleeve
gastrectomy).
The tertiary objectives of this study are to report the number of respiratory complications
and postoperative wound infections at the 30th postoperative day.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - ASA score (American Society of Anesthesiologists ) of II or III - BMI > 35 kg/m² - Elective laparoscopic bariatric surgery: gastric bypass or sleeve Exclusion Criteria: - Restrictive (CPT <65%) or obstructive (VEMS/CV < 69%) chronic lung disease - Increase of the intracranial pressure - History of smoking with chronic obstructive disease (VEMS/CV) - Active tabagism - Ongoing pregnancy - History of heart failure (NYHA III or IV) or coronary artery disease - Urgent surgery - Allergy to a drug used within the study - Lack of written informed consent |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann | Brussels |
Lead Sponsor | Collaborator |
---|---|
Brugmann University Hospital |
Belgium,
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. Epub 2009 Apr 29. — View Citation
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Futier E, Constantin JM, Pelosi P, Chanques G, Kwiatkoskwi F, Jaber S, Bazin JE. Intraoperative recruitment maneuver reverses detrimental pneumoperitoneum-induced respiratory effects in healthy weight and obese patients undergoing laparoscopy. Anesthesiology. 2010 Dec;113(6):1310-9. doi: 10.1097/ALN.0b013e3181fc640a. — View Citation
Gander S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Positive end-expiratory pressure during induction of general anesthesia increases duration of nonhypoxic apnea in morbidly obese patients. Anesth Analg. 2005 Feb;100(2):580-4. — View Citation
Gattinoni L, Carlesso E, Brazzi L, Caironi P. Positive end-expiratory pressure. Curr Opin Crit Care. 2010 Feb;16(1):39-44. doi: 10.1097/MCC.0b013e3283354723. Review. — View Citation
Hans GA, Sottiaux TM, Lamy ML, Joris JL. Ventilatory management during routine general anaesthesia. Eur J Anaesthesiol. 2009 Jan;26(1):1-8. doi: 10.1097/EJA.0b000e000000f1fb. Review. — View Citation
Imberger G, McIlroy D, Pace NL, Wetterslev J, Brok J, Møller AM. Positive end-expiratory pressure (PEEP) during anaesthesia for the prevention of mortality and postoperative pulmonary complications. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007922. doi: 10.1002/14651858.CD007922.pub2. Review. Update in: Cochrane Database Syst Rev. 2014;6:CD007922. — View Citation
Maisch S, Reissmann H, Fuellekrug B, Weismann D, Rutkowski T, Tusman G, Bohm SH. Compliance and dead space fraction indicate an optimal level of positive end-expiratory pressure after recruitment in anesthetized patients. Anesth Analg. 2008 Jan;106(1):175-81, table of contents. doi: 10.1213/01.ane.0000287684.74505.49. — View Citation
Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L; Expiratory Pressure (Express) Study Group. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646-55. doi: 10.1001/jama.299.6.646. — View Citation
Pelosi P, Ravagnan I, Giurati G, Panigada M, Bottino N, Tredici S, Eccher G, Gattinoni L. Positive end-expiratory pressure improves respiratory function in obese but not in normal subjects during anesthesia and paralysis. Anesthesiology. 1999 Nov;91(5):1221-31. — 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
Strang CM, Hachenberg T, Fredén F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of hypoxemia episodes (Sp02<90%) | This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<90%) and their duration in obese patients, in the postoperative period. | continuously during 48h after surgery | |
Primary | Number of hypoxemia episodes (Sp02<95%) | This will be monitored by a portable saturometer (OxyTrue A, Bluepoint, Germany). This saturometer will allow the investigators to count the number of hypoxemia episodes (Sp02<95%) and their duration in obese patients, in the postoperative period. | continuously during 48h after surgery | |
Secondary | Number of recruitment manoeuvers | Recruitment manoeuver are performed if patient saturation drops below 95%. | From the beginning of the surgery till moment 1 (after induction/intubation, patient laying flat, without pneumoperitoneum) | |
Secondary | Number of recruitment manoeuvers | Recruitment manoeuver are performed if patient saturation drops below 95%. | From moment 1 till moment 2 (after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation) | |
Secondary | Number of recruitment manoeuvers | Recruitment manoeuver are performed if patient saturation drops below 95%. | From moment 2 till moment 3 (after pneumoperitoneum exsufflation - patient lying flat) | |
Secondary | Number of recruitment manoeuvers | Recruitment manoeuver are performed if patient saturation drops below 95%. | From moment 3 till the end of the surgery (patient leaving the theater) | |
Secondary | Pulmonary dynamic compliance (Cd) - preoperative | This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O | Just before surgery, at ambient air contact | |
Secondary | Pulmonary dynamic compliance (Cd) - moment 1 | This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O | just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory | |
Secondary | Pulmonary dynamic compliance (Cd) -moment 2 | This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Pulmonary dynamic compliance (Cd) -moment 3 | This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Pulmonary dynamic compliance (Cd) -if recruitment manoeuvers | This will be determined by the following formula: Cd = Vt/P(peak)-PEEP and expressed in mL/cmH2O | Five minutes after any recruitment manoeuver | |
Secondary | Anatomic dead space - preoperative | This will be determined by this formula: VD = VT (1-PEtCO2/PaC02) | Just before surgery, at ambient air contact | |
Secondary | Anatomic dead space -moment 1 | This will be determined by this formula: VD = VT (1-PEtCO2/PaC02) | just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory | |
Secondary | Anatomic dead space -moment 2 | This will be determined by this formula: VD = VT (1-PEtCO2/PaC02) | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Anatomic dead space -moment 3 | This will be determined by this formula: VD = VT (1-PEtCO2/PaC02) | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Anatomic dead space -if recruitment manoeuvers | This will be determined by this formula: VD = VT (1-PEtCO2/PaC02) | Five minutes after any recruitment manoeuver | |
Secondary | PaO2/FiO2 ratio - preoperative | Arterial oxygen partial pressure to fractional inspired oxygen ratio | Just before surgery, at ambient air contact | |
Secondary | PaO2/FiO2 ratio - moment 1 | Arterial oxygen partial pressure to fractional inspired oxygen ratio | just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory | |
Secondary | PaO2/FiO2 ratio - moment 2 | Arterial oxygen partial pressure to fractional inspired oxygen ratio | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | PaO2/FiO2 ratio - moment 3 | Arterial oxygen partial pressure to fractional inspired oxygen ratio | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | PaO2/FiO2 ratio - if recruitment manoeuvers | Arterial oxygen partial pressure to fractional inspired oxygen ratio | Five minutes after any recruitment manoeuver | |
Secondary | PaCO2-EtCO2 gradient - preoperative | The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment. | Just before surgery, at ambient air contact | |
Secondary | PaCO2-EtCO2 gradient - moment 1 | The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment. | just after the anesthesia induction/intubation, patient laying flat, without pneumoperitory | |
Secondary | PaCO2-EtCO2 gradient - moment 2 | The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment. | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | PaCO2-EtCO2 gradient - moment 3 | The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment. | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | PaCO2-EtCO2 gradient - if recruitment manoeuvers | The gradient between the partial pressure of carbon dioxide in the arterial blood (PaCO2) and the CO2 end-tidal partial pressure (EtCO2) is used to evaluate the effectiveness of alveolar recruitment. | Five minutes after any recruitment manoeuver | |
Secondary | Number of respiratory complications | Number of hospitalisations due to respiratory complications within 30 days after surgery. | 30 days after surgery | |
Secondary | Number of postoperative wound infections | All patients are seen at the surgical consultation on day 30 after surgery. The anamnesis performed during that consultation enables the investigators to identify patients with wound infections (defined as a need for local or oral antibiotics, additional hospitalisation or abnormal cicatrisation). | 30 days after surgery | |
Secondary | Pre-operative physiologic measures: cardiac frequency (FC) | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | Just before surgery, at ambient air contact | |
Secondary | Pre-operative physiologic measures: Arterial tension (TA) | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | Just before surgery, at ambient air contact | |
Secondary | Pre-operative physiologic measures: pH | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | Just before surgery, at ambient air contact | |
Secondary | Pre-operative physiologic measures: partial pressure of carbon dioxide in the arterial blood (PaCO2) | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens). | Just before surgery, at ambient air contact | |
Secondary | Operative physiologic measures - moment 1: FC | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after induction/intubation, patient laying flat, without pneumoperitoneum | |
Secondary | Operative physiologic measures - moment 1: PAM (Average arterial pressure) | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after induction/intubation, patient laying flat, without pneumoperitoneum | |
Secondary | Operative physiologic measures - moment 1: pH | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after induction/intubation, patient laying flat, without pneumoperitoneum | |
Secondary | Operative physiologic measures - moment 1: PaCO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after induction/intubation, patient laying flat, without pneumoperitoneum | |
Secondary | Operative physiologic measures - moment 1: CO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after induction/intubation, patient laying flat, without pneumoperitoneum | |
Secondary | Operative physiologic measures - moment 2: FC | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Operative physiologic measures - moment 2: PAM | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Operative physiologic measures - moment 2: pH | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Operative physiologic measures - moment 2: PaCO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Operative physiologic measures - moment 2: CO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Operative physiologic measures - moment 3: FC | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Operative physiologic measures - moment 3: PAM | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Operative physiologic measures - moment 3: pH | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Operative physiologic measures - moment 3: CO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Operative physiologic measures - moment 3: PaCO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Operative physiologic measures - if recruitment manoeuvers occurs: FC | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | Five minutes after any recruitment manoeuver | |
Secondary | Operative physiologic measures - if recruitment manoeuvers occurs: PAM | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | Five minutes after any recruitment manoeuver | |
Secondary | Operative physiologic measures - if recruitment manoeuvers occurs: SpO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | Five minutes after any recruitment manoeuver | |
Secondary | Operative physiologic measures - if recruitment manoeuvers occurs: pH | The hemodynamic and respiratory parameters of the patient are measured by means of a Datex-Ohmeda Acertys machine (Aisys type). | Five minutes after any recruitment manoeuver | |
Secondary | Operative physiologic measures - if recruitment manoeuvers occurs: PaCO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | Five minutes after any recruitment manoeuver | |
Secondary | Operative physiologic measures - if recruitment manoeuvers occurs: PaO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | Five minutes after any recruitment manoeuver | |
Secondary | Operative physiologic measures - if recruitment manoeuvers occurs: CO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | Five minutes after any recruitment manoeuver | |
Secondary | Pre-operative physiologic measures: partial pressure of oxygen in the arterial blood (PaO2) | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | Just before surgery, at ambient air contact | |
Secondary | Operative physiologic measures - moment 1: PaO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after induction/intubation, patient laying flat, without pneumoperitoneum | |
Secondary | Operative physiologic measures - moment 2: PaO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Operative physiologic measures - moment 3: PaO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after pneumoperitoneum exsufflation - patient lying flat | |
Secondary | Pre-operative physiologic measures: Oxygen Pulsated Saturation (SpO2) | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | Just before surgery, at ambient air contact | |
Secondary | Operative physiologic measures - moment 1: SpO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after induction/intubation, patient laying flat, without pneumoperitoneum | |
Secondary | Operative physiologic measures - moment 2: SpO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after peritoneal insufflation and anti-trendenlenbourg (anti-trent) implementation | |
Secondary | Operative physiologic measures - moment 3: SpO2 | The gasometric parameters of the patient are analyzed with a Rapidlab 1265 machine (Siemens) | just after pneumoperitoneum exsufflation - patient lying flat |
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