Ultrasonograpahic Evaluation of Diaphragmatic Functions in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

NCT04130217 | Completed

• 1 other identifier: 5610/20-1-2019
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Major laparoscopic sleeve gastrectomy surgery requires steep Trendelenburg position with pneumoperitoneum for a long time leading to decrease pulmonary compliance and lung volumes due to cephalic displacement and decrease excursion of the diaphragm, consequently leading to the possibility of atelectasis formation. Different strategies have been proposed to reduce atelectasis and other pulmonary complications in obese patients as induction of anesthesia in the head up position with or without CPAP, protective intraoperative mechanical ventilation with high or low levels of PEEP and implementation of Recruitment Maneuvers. Up to investigators' knowledge, there is no study done to evaluate the effect of intraoperative use of PEEP and alveolar recruitment maneuver on diaphragmatic function and incidence of atelectasis via ultrasonography in obese patients undergoing laparoscopic sleeve gastrectomy.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• changes of Diaphragmatic excursion (DD)

  will be measured by low frequency probe of Sonosite M Turbo ultrasonography, measurements will be taken before induction of anaesthesia, 5 min after completion of pneumoperitoneum, 5 min after adopting Trendelenburg position, 60 min later with pneumoperitoneum and Trendelenburg position, 5 min after exsufflation of pneumoperitoneum and patient placed back in the supine position, 15 min after arrival of patient in the recovery room and 24h postoperatively.

  24 hour postoperative

Secondary Outcomes (1)

• Incidence of lung atelectasis

  24 hour postoperative

Study Arms (3)

Control group

NO INTERVENTION

patients will be intraoperatively mechanically ventilated without PEEP nor RM.

PEEP Group

EXPERIMENTAL

patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O.

Procedure: addition of positive end expiratory pressure in ventilated patients

PEEP and RM Group

EXPERIMENTAL

patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O and intermittent four times of RM consisting of maintaining airway pressure 40 cmH2O for 40 sec.

Procedure: addition of positive end expiratory pressure and recruitment maneuver in ventilated patients

Interventions

addition of positive end expiratory pressure in ventilated patients PROCEDURE

patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O.

PEEP Group

addition of positive end expiratory pressure and recruitment maneuver in ventilated patients PROCEDURE

patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O and intermittent four times of RM consisting of maintaining airway pressure 40 cmH2O for 40 sec.

PEEP and RM Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• Age 21-60 years old.
• BMI ≥35 kg/m2
• ASA II and ASA III.
• Elective laparoscopic sleeve gastrectomy under general anesthesia.

You may not qualify if:

• Preoperative diagnosis of obstructive sleep apnea by using the STOP-BANG questionnaire (Snoring, Tiredness during the daytime, observed apnea, high blood pressure, Body mass index over 35, Age, Neck circumference, and Gender)
• History of pneumothorax or right-side heart failure.
• History of chronic respiratory disease, diaphragmatic disease, or neuromuscular disease.
• Any contraindication for laparoscopic surgery or head-down position.
• Any history with post esophageal or thoracic surgeries due to intraoperative diaphragmatic manipulation.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (7)

• Felsenreich DM, Prager G, Kefurt R, Eilenberg M, Jedamzik J, Beckerhinn P, Bichler C, Sperker C, Krebs M, Langer FB. Quality of Life 10 Years after Sleeve Gastrectomy: A Multicenter Study. Obes Facts. 2019;12(2):157-166. doi: 10.1159/000496296. Epub 2019 Mar 15.

  PMID: 30879011 BACKGROUND

• Guetta O, Vakhrushev A, Dukhno O, Ovnat A, Sebbag G. New results on the safety of laparoscopic sleeve gastrectomy bariatric procedure for type 2 diabetes patients. World J Diabetes. 2019 Feb 15;10(2):78-86. doi: 10.4239/wjd.v10.i2.78.

  PMID: 30788045 BACKGROUND

• 3- Sarandan M, Guragata-Balasa C, Papurica M, Duta C, Hordovan E, Rus C, et al. Anesthesia in laparoscopic bariatric surgery (gastric sleeve) - preliminary experience. TMJ 2011; 61(1): 26-31.

  BACKGROUND

• 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

• Suh MK, Seong KW, Jung SH, Kim SS. The effect of pneumoperitoneum and Trendelenburg position on respiratory mechanics during pelviscopic surgery. Korean J Anesthesiol. 2010 Nov;59(5):329-34. doi: 10.4097/kjae.2010.59.5.329. Epub 2010 Nov 25.

  PMID: 21179295 BACKGROUND

• 6- Rashwan DAE, Mahmoud HE, Nofal WH, Sabek EA. Ultrasonographic Evaluation of the Effect of Positive End-expiratory Pressure on Diaphragmatic Functions in Patients Undergoing Laparoscopic Colorectal Surgery: A Prospective Randomized Comparative Study. J Anesth Clin Res. 2018; 9(7): 843-51.

  BACKGROUND

• Matamis D, Soilemezi E, Tsagourias M, Akoumianaki E, Dimassi S, Boroli F, Richard JC, Brochard L. Sonographic evaluation of the diaphragm in critically ill patients. Technique and clinical applications. Intensive Care Med. 2013 May;39(5):801-10. doi: 10.1007/s00134-013-2823-1. Epub 2013 Jan 24.

  PMID: 23344830 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 17, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after the publication of the study
• Access Criteria: contact of principal investigator

Locations

EG (1)