Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery

Not Applicable

Completed

• Conditions: Abdominal Surgery; Obese Patients
• Interventions: Other: spontanous ventilation; Other: ARM

• Registration Number: NCT04506736
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Study Start: 2020-08-15
• Primary Completion: 2022-03-30
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPV spontanous ventilation	spontanous ventilation	The patients 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 .
OLA open lung ventilation	ARM	The patients will undergo ARM followed by personalized PEEP.

Primary Outcome Measures

Name	Time	Method
post-operative pulmonary complications	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 Outcome Measures

Name	Time	Method
heart rate	Baseline (before surgery) and intraoperative	hemodynamic changes
pulmonary complications.	one week postoperative	1. Postoperative pulmonary complications which are defined as having one or more of the following: 1.Pneumonia 2. Respiratory failure requiring mechanical ventilation (Postoperative PaO2 \< 60 mm Hg on room air, a PaO2:FiO2 ratio \< 300 mm Hg) or peripheral oxygen saturation (SpO₂) \<90% and requiring oxygen therapy ). 3. Atelectasis requiring bronchoscopic intervention 4. Pulmonary edema ( postoperative acute lung injury or ARDS). 5. Delayed tracheal extubation ( \>24 hours postoperatively) or need for reintubation (because of respiratory distress, hypoxia, hypercarbia, or respiratory acidosis). 6. Pneumothorax 7. Bronchospasm (Newly detected refractory expiratory wheeze requiring bronchodilators
length of hospital stay,	postoperative up to one month	the length of hospital stay, and 30 days mortality.
mean arterial blood pressure	Baseline (before surgery) and intraoperative	hemodynamic changes
airway pressure	intraoperative	During mechanical ventilation airway pressures will be continuously monitored.
tidal volume	intraoperative	During mechanical ventilation tidal volume will be continuously monitored.
SpO2	Baseline (before surgery) and intraoperative	hemodynamic changes
ETCO2	Baseline (before surgery) and intraoperative	hemodynamic changes

Trial Locations

Locations (1)

Faculty of Medicine,Zagazig University; 🇪🇬 Zagazig, Zagazig, Elsharkia,egypt, Egypt