Skip to main content
Clinical Trials/NCT04506736
NCT04506736
Completed
Not Applicable

Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial

Zagazig University1 site in 1 country48 target enrollmentAugust 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abdominal Surgery
Sponsor
Zagazig University
Enrollment
48
Locations
1
Primary Endpoint
post-operative pulmonary complications
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery

Detailed Description

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery . Group OLA: The patients will undergo ARM followed by personalized PEEP.

Registry
clinicaltrials.gov
Start Date
August 15, 2020
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Mohamed Medhat

lecture of anesthesia and surgical intensive care (Principal Investigator)

Zagazig University

Eligibility Criteria

Inclusion Criteria

  • Patient aged between 18 - 65 years
  • BMI between 30-40 kg/m²
  • ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery

Exclusion Criteria

  • Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 \< 80% of the predicted value)
  • active asthma, acute respiratory distress syndrome
  • history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
  • significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension

Outcomes

Primary Outcomes

post-operative pulmonary complications

Time Frame: one week postoperative

Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.

Secondary Outcomes

  • heart rate(Baseline (before surgery) and intraoperative)
  • length of hospital stay,(postoperative up to one month)
  • pulmonary complications.(one week postoperative)
  • mean arterial blood pressure(Baseline (before surgery) and intraoperative)
  • airway pressure(intraoperative)
  • tidal volume(intraoperative)
  • SpO2(Baseline (before surgery) and intraoperative)
  • ETCO2(Baseline (before surgery) and intraoperative)

Study Sites (1)

Loading locations...

Similar Trials