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

NCT ID: NCT04506736

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2022-04-30

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.

Conditions

Abdominal Surgery; Obese Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

SPV 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 .

Group Type: ACTIVE_COMPARATOR

spontanous ventilation

Intervention Type: OTHER

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

The patients will undergo ARM followed by personalized PEEP.

Group Type: ACTIVE_COMPARATOR

ARM

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

spontanous ventilation

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

Intervention Type: OTHER

Other Intervention Names

followed by personalized PEEP.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marwa Mohamed Medhat

lecture of anesthesia and surgical intensive care (Principal Investigator)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howida A kamal, M.D

Role: STUDY_DIRECTOR

zagazig U

Locations

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, Egypt

Countries

Egypt

Other Identifiers

6204

Identifier Type: -

Identifier Source: org_study_id