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

Zagazig University48 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Abdominal Surgery Obese Patients

Interventions

ARMOTHER

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 ventilationOTHER

volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, Egypt

Outcomes

Primary Outcomes

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.

Time frame: one week postoperative

Secondary Outcomes

heart rate

hemodynamic changes

Time frame: Baseline (before surgery) and intraoperative

airway pressure

During mechanical ventilation airway pressures will be continuously monitored.

Time frame: intraoperative

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

Time frame: one week postoperative

length of hospital stay,

the length of hospital stay, and 30 days mortality.

Time frame: postoperative up to one month

mean arterial blood pressure

hemodynamic changes

Time frame: Baseline (before surgery) and intraoperative

Data from ClinicalTrials.gov

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