Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients

NCT03024658 | Completed

• 1 other identifier: Saims/IEC/14/02/35
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Morbid Obesity

Keywords

Pulmonary artery systolic pressure; Positive end expiratory pressure; morbidly obese; laparoscopic bariatric surgery

Outcome Measures

Primary Outcomes (20)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (20)

• Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

  ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

• Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

  ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

• Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

  ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

• Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

  ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

• Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

  ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

Study Arms (2)

Zero PEEP

NO INTERVENTION

This group of patients did not receive any PEEP at the time of induction of general anesthesia (n= 30)

PEEP- 10 cm of H2O

EXPERIMENTAL

This group comprised of patients who received a PEEP of 10 cm H2O at the time of induction of general anesthesia (n= 30)

Other: positive end expiratory pressure (PEEP)

Interventions

positive end expiratory pressure (PEEP) OTHER

Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery

PEEP- 10 cm of H2O

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anesthesia society of Anesthesiologist (ASA) physical status l, II or III,
• Aged 20-65 years
• BMI \> 40kg/m2
• scheduled for elective laparoscopic bariatric surgery

You may not qualify if:

• Patients who denied consent
• patients undergoing Emergency and/or open surgery
• Patients requiring more than 2 attempts for intubation

Sponsors & Collaborators

• Sri Aurobindo Institute of Medical Sciences: lead

Related Publications (12)

• Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden 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.

  PMID: 19809292 BACKGROUND

• 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. doi: 10.1152/jappl.1997.82.3.811.

  PMID: 9074968 RESULT

• 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. doi: 10.1097/00000539-200212000-00060.

  PMID: 12456460 RESULT

• 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. doi: 10.1213/01.ane.0000111743.61132.99.

  PMID: 15105237 RESULT

• 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.

  PMID: 19403595 RESULT

• 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. doi: 10.1164/ajrccm.164.1.2007010.

  PMID: 11435250 RESULT

• 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. Acta Anaesthesiol Scand. 2004 Jan;48(1):82-92. doi: 10.1111/j.1399-6576.2004.00265.x.

  PMID: 14674978 RESULT

• 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 Dec;69(6):824-32. doi: 10.1097/00000542-198812000-00005.

  PMID: 3057937 RESULT

• 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 Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.

  PMID: 11549535 RESULT

• 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. doi: 10.1097/00005382-198807000-00013.

  PMID: 3292784 RESULT

• Fougeres 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.0b013e3181c587fd.

  PMID: 19926983 RESULT

• 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. doi: 10.1161/hc4801.100076.

  PMID: 11733397 RESULT

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Anaesthesiology

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 19, 2017
• Study Start: May 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share