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

NCT04506736 | Completed

• 1 other identifier: 6204
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Surgery; Obese Patients

Keywords

Open lung approach; conventional ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• heart rate

  Baseline (before surgery) and intraoperative

• airway pressure

  intraoperative

• pulmonary complications.

  one week postoperative

• length of hospital stay,

  postoperative up to one month

• mean arterial blood pressure

  Baseline (before surgery) and intraoperative

Study Arms (2)

SPV spontanous ventilation

ACTIVE COMPARATOR

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 .

Other: spontanous ventilation

OLA open lung ventilation

ACTIVE COMPARATOR

The patients will undergo ARM followed by personalized PEEP.

Other: ARM

Interventions

ARM 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.

Also known as: followed by personalized PEEP.

OLA open lung ventilation

spontanous ventilation OTHER

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

SPV spontanous ventilation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, 44519, Egypt

Location

Study Officials

• Howida A kamal, M.D

  zagazig U

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant, Care Provider
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 10, 2020
• Study Start: August 15, 2020
• Primary Completion: March 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

EG (1)