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

Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506736
• Other study ID #: 6204
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Obese Patients
• Obesity

Intervention

Other:
• ARM
The ARM is performed by setting the peak inspiratory pressure to 45 cmH2O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH2O. The PEEP level is then increased in 5 cmH2O steps every minute till it reaches 20 cmH2O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH2O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH2O. The titration of individualized PEEP is done by decremental reduction of the 20 cmH2O PEEP level in 2 cmH2O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step.
• spontanous ventilation
volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H2O fixed PEEP till the end of the surgery .

Locations

Country	Name	City	State
Egypt	Faculty of Medicine,Zagazig University	Zagazig	Zagazig, Elsharkia,egypt

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative pulmonary complications	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.	one week postoperative
Secondary	heart rate	hemodynamic changes	Baseline (before surgery) and intraoperative
Secondary	airway pressure	During mechanical ventilation airway pressures will be continuously monitored.	intraoperative
Secondary	pulmonary complications.	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	one week postoperative
Secondary	length of hospital stay,	the length of hospital stay, and 30 days mortality.	postoperative up to one month
Secondary	mean arterial blood pressure	hemodynamic changes	Baseline (before surgery) and intraoperative
Secondary	ETCO2	hemodynamic changes	Baseline (before surgery) and intraoperative
Secondary	tidal volume	During mechanical ventilation tidal volume will be continuously monitored.	intraoperative
Secondary	SpO2	hemodynamic changes	Baseline (before surgery) and intraoperative