Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

The Effect of Bi-PAP at Individualized Pressures on the Postoperative Pulmonary Recovery of Morbidly Obese Patients (MOP) Undergoing Open Bariatric Surgery (OBS) and Possible Placebo Device-related Effects (Sham-Bi-PAP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438383
• Other study ID #: 142/23-05-2011
• Status: Completed
• Phase: N/A
• Start date: May 23, 2011
• Est. completion date: May 31, 2012

Study information

• Verified date: November 2020
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated.

Description:

In the present study the effect of Bi-PAP on the postoperative respiratory function and related complications of MOP undergoing OBS through a randomized sham-controlled design was investigated. Bi-PAP was applied at individualized pressures in order to optimize respiratory support and sham Bi-PAP was also used in order to neutralize possible placebo device related effect and researcher related bias.

The investigators hypothesized that the use of Bi-PAP at individualized pressures in MOP undergoing OBS, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. Primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (forced expiratory volume at one second (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and oxygen saturation by pulse oximetry (SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 31, 2012
• Est. primary completion date: May 22, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients have been Morbidly Obese (BMI> 40kg/m2) for at least 10 years

• All patients had unsuccessfully tried to lose weight by other non-invasive means.

• All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment

• All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team

• All patients were treated with the same standard anesthetic protocol

Exclusion Criteria:

• Cardiovascular and pulmonary disease not related to obesity status

• Chronic renal disease

• Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.

Related Conditions & MeSH terms

• Atelectasis
• Chronic Obstructive Pulmonary Disease (COPD)
• Hypoxemia
• Hypoxemic Respiratory Failure
• Hypoxia
• Lung Diseases
• Lung Diseases, Obstructive
• Morbid Obesity
• Obesity, Morbid
• Pulmonary Atelectasis
• Pulmonary Disease
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Infection
• Respiratory Insufficiency

Intervention

Device:
• Bi-PAP
The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
• Sham Bi-PAP
Sham Bi-PAP was created by introducing a "hole" at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Evangelismos Hospital	Elpis General Hospital, Evgenidion Hospital, Sotiria General Hospital

References & Publications (40)

Aguiló R, Togores B, Pons S, Rubí M, Barbé F, Agustí AG. Noninvasive ventilatory support after lung resectional surgery. Chest. 1997 Jul;112(1):117-21. — View Citation

Alexandropoulou AN, Louis K, Papakonstantinou A, Tzirogiannis K, Stamataki E, Roussos C, Alchanatis M, Gratziou C, Vagiakis E, Roditis K. The influence of biphasic positive airway pressure vs. sham biphasic positive airway pressure on pulmonary function i — View Citation

Ambrosino N, Gabbrielli L. Physiotherapy in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):283-9. Review. — View Citation

Casati A, Putzu M. Anesthesia in the obese patient: pharmacokinetic considerations. J Clin Anesth. 2005 Mar;17(2):134-45. Review. — View Citation

Charghi R, Backman S, Christou N, Rouah F, Schricker T. Patient controlled i.v. analgesia is an acceptable pain management strategy in morbidly obese patients undergoing gastric bypass surgery. A retrospective comparison with epidural analgesia. Can J Anaesth. 2003 Aug-Sep;50(7):672-8. — View Citation

Cobbold A, Lord S. Treatment and management of obesity: is surgical intervention the answer? J Perioper Pract. 2012 Apr;22(4):114-21. — View Citation

Crapo RO. Pulmonary-function testing. N Engl J Med. 1994 Jul 7;331(1):25-30. Review. — View Citation

Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. Epub 2012 Jul 26. Review. — View Citation

Ebeo CT, Benotti PN, Byrd RP Jr, Elmaghraby Z, Lui J. The effect of bi-level positive airway pressure on postoperative pulmonary function following gastric surgery for obesity. Respir Med. 2002 Sep;96(9):672-6. — 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

Gifford AH, Leiter JC, Manning HL. Respiratory function in an obese patient with sleep-disordered breathing. Chest. 2010 Sep;138(3):704-15. doi: 10.1378/chest.09-3030. — View Citation

Gust R, Gottschalk A, Schmidt H, Böttiger BW, Böhrer H, Martin E. Effects of continuous (CPAP) and bi-level positive airway pressure (BiPAP) on extravascular lung water after extubation of the trachea in patients following coronary artery bypass grafting. Intensive Care Med. 1996 Dec;22(12):1345-50. — View Citation

Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75. Review. — View Citation

Huerta S, DeShields S, Shpiner R, Li Z, Liu C, Sawicki M, Arteaga J, Livingston EH. Safety and efficacy of postoperative continuous positive airway pressure to prevent pulmonary complications after Roux-en-Y gastric bypass. J Gastrointest Surg. 2002 May-Jun;6(3):354-8. — View Citation

Joris JL, Sottiaux TM, Chiche JD, Desaive CJ, Lamy ML. Effect of bi-level positive airway pressure (BiPAP) nasal ventilation on the postoperative pulmonary restrictive syndrome in obese patients undergoing gastroplasty. Chest. 1997 Mar;111(3):665-70. — View Citation

Kyzer S, Ramadan E, Gersch M, Chaimoff C. Patient-Controlled Analgesia Following Vertical Gastroplasty: a Comparison with Intramuscular Narcotics. Obes Surg. 1995 Feb;5(1):18-21. — View Citation

Lawrence VA, Dhanda R, Hilsenbeck SG, Page CP. Risk of pulmonary complications after elective abdominal surgery. Chest. 1996 Sep;110(3):744-50. — View Citation

Littleton SW. Impact of obesity on respiratory function. Respirology. 2012 Jan;17(1):43-9. doi: 10.1111/j.1440-1843.2011.02096.x. Review. — View Citation

Loadsman JA, Hillman DR. Anaesthesia and sleep apnoea. Br J Anaesth. 2001 Feb;86(2):254-66. Review. — View Citation

Lumb AB, Greenhill SJ, Simpson MP, Stewart J. Lung recruitment and positive airway pressure before extubation does not improve oxygenation in the post-anaesthesia care unit: a randomized clinical trial. Br J Anaesth. 2010 May;104(5):643-7. doi: 10.1093/bja/aeq080. Epub 2010 Mar 30. — View Citation

Mehta S, Hill NS. Noninvasive ventilation. Am J Respir Crit Care Med. 2001 Feb;163(2):540-77. Review. — View Citation

Moritz F, Brousse B, Gellée B, Chajara A, L'Her E, Hellot MF, Bénichou J. Continuous positive airway pressure versus bilevel noninvasive ventilation in acute cardiogenic pulmonary edema: a randomized multicenter trial. Ann Emerg Med. 2007 Dec;50(6):666-75, 675.e1. Epub 2007 Aug 30. — View Citation

Nava S, Carbone G, DiBattista N, Bellone A, Baiardi P, Cosentini R, Marenco M, Giostra F, Borasi G, Groff P. Noninvasive ventilation in cardiogenic pulmonary edema: a multicenter randomized trial. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1432-7. Epub 2003 Sep 4. — View Citation

Neligan PJ, Malhotra G, Fraser M, Williams N, Greenblatt EP, Cereda M, Ochroch EA. Continuous positive airway pressure via the Boussignac system immediately after extubation improves lung function in morbidly obese patients with obstructive sleep apnea undergoing laparoscopic bariatric surgery. Anesthesiology. 2009 Apr;110(4):878-84. doi: 10.1097/ALN.0b013e31819b5d8c. — View Citation

Nguyen NT, Lee SL, Goldman C, Fleming N, Arango A, McFall R, Wolfe BM. Comparison of pulmonary function and postoperative pain after laparoscopic versus open gastric bypass: a randomized trial. J Am Coll Surg. 2001 Apr;192(4):469-76; discussion 476-7. — View Citation

Parameswaran K, Todd DC, Soth M. Altered respiratory physiology in obesity. Can Respir J. 2006 May-Jun;13(4):203-10. Review. — View Citation

Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. Review. — View Citation

Pelosi P, Jaber S. Noninvasive respiratory support in the perioperative period. Curr Opin Anaesthesiol. 2010 Apr;23(2):233-8. doi: 10.1097/ACO.0b013e328335daec. Review. — View Citation

Radunovic A, Annane D, Rafiq MK, Mustfa N. Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD004427. doi: 10.1002/14651858.CD004427.pub3. Review. Update in: Cochrane Database Syst Rev. 2017 Oct 06;10 :CD004427. — View Citation

Ramirez A, Lalor PF, Szomstein S, Rosenthal RJ. Continuous positive airway pressure in immediate postoperative period after laparoscopic Roux-en-Y gastric bypass: is it safe? Surg Obes Relat Dis. 2009 Sep-Oct;5(5):544-6. doi: 10.1016/j.soard.2009.05.007. Epub 2009 Jun 23. — View Citation

Renston JP, DiMarco AF, Supinski GS. Respiratory muscle rest using nasal BiPAP ventilation in patients with stable severe COPD. Chest. 1994 Apr;105(4):1053-60. — View Citation

Salome CM, King GG, Berend N. Physiology of obesity and effects on lung function. J Appl Physiol (1985). 2010 Jan;108(1):206-11. doi: 10.1152/japplphysiol.00694.2009. Epub 2009 Oct 29. Review. — View Citation

Simonneau G, Vivien A, Sartene R, Kunstlinger F, Samii K, Noviant Y, Duroux P. Diaphragm dysfunction induced by upper abdominal surgery. Role of postoperative pain. Am Rev Respir Dis. 1983 Nov;128(5):899-903. — View Citation

Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. — View Citation

Talab HF, Zabani IA, Abdelrahman HS, Bukhari WL, Mamoun I, Ashour MA, Sadeq BB, El Sayed SI. Intraoperative ventilatory strategies for prevention of pulmonary atelectasis in obese patients undergoing laparoscopic bariatric surgery. Anesth Analg. 2009 Nov;109(5):1511-6. doi: 10.1213/ANE.0b013e3181ba7945. — View Citation

Thomas JA, McIntosh JM. Are incentive spirometry, intermittent positive pressure breathing, and deep breathing exercises effective in the prevention of postoperative pulmonary complications after upper abdominal surgery? A systematic overview and meta-analysis. Phys Ther. 1994 Jan;74(1):3-10; discussion 10-6. — View Citation

Thys F, Roeseler J, Reynaert M, Liistro G, Rodenstein DO. Noninvasive ventilation for acute respiratory failure: a prospective randomised placebo-controlled trial. Eur Respir J. 2002 Sep;20(3):545-55. — View Citation

Vasquez TL, Hoddinott K. A potential complication of bi-level positive airway pressure after gastric bypass surgery. Obes Surg. 2004 Feb;14(2):282-4. — View Citation

Vassilakopoulos T, Mastora Z, Katsaounou P, Doukas G, Klimopoulos S, Roussos C, Zakynthinos S. Contribution of pain to inspiratory muscle dysfunction after upper abdominal surgery: A randomized controlled trial. Am J Respir Crit Care Med. 2000 Apr;161(4 Pt 1):1372-5. — View Citation

Wong DT, Adly E, Ip HY, Thapar S, Maxted GR, Chung FF. A comparison between the Boussignac™ continuous positive airway pressure mask and the venturi mask in terms of improvement in the PaO2/F(I)O2 ratio in morbidly obese patients undergoing bariatric surgery: a randomized controlled trial. Can J Anaesth. 2011 Jun;58(6):532-9. doi: 10.1007/s12630-011-9497-3. Epub 2011 Apr 5. — View Citation

* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume at One Second (FEV1) Difference	difference in FEV1 value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 h post-operatively
Primary	Forced Vital Capacity (FVC) Difference	difference in FVC value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 hours post-operatively
Primary	Peak Expiratory Flow Rate (PEFR) Difference	difference in PEFR value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 hours post-operatively
Primary	SpO2 Difference	difference in SpO2 value measured by spirometry pre- and post-operatively	24 h before surgery and at 24, 48 and 72 hours post-operatively
Primary	Number of Participants With Hypoxemia	occurrence of hypoxemia, considered as SpO2<90%, post-operatively	At 24, 48 and 72 hours post-operatively
Primary	Number of Participants With Atelectasis	occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline	At 24, 48 and 72 hours post-operatively
Secondary	Post-operative Pain	Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)	right before spirometry, at 24, 48 and 72 h post-operatively
Secondary	Days of Hospitalization	duration of hospitalization, calculated by discharge date minus admission date	From day of admission to day of discharge from the hospital

External Links

•   Publication of Study Results