Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery

NCT03165760 | Completed

• 1 other identifier: Mongi Slim OR
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized controlled trial, comparing two groups of 40 patients each scheduled for open major abdominal surgery. The intervention group was ventilated with a protective strategy consisting on a low Tidal volume (Vt) (6ml/kg of predicted body weight (PBW)), positive end expiratory pressure (PEEP) = 10 cm H2O and recruitment manoeuvres (RM) after disconnection from the ventilator, the control group had classic ventilation (Vt = 8 ml/kg of PBW, PEEP = 4 cmH2O and no RM).

Conditions

Ventilator-Induced Lung Injury; Mechanical Ventilation Complication; Postoperative Complications

Keywords

protective mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Postoperative pulmonary complications

  Postoperative pulmonary complications occurring within the first 7 days after surgery (defined as hypoxemia, Broncho pneumopathy, pulmonary infiltrate, acute respiratory distress syndrome, atelectasis, pleural effusion)

  Postoperative pulmonary complications within the first 7 days after surgery

Study Arms (2)

control group

NO INTERVENTION

Vt = 8 ml/kg of PBW and PEEP = 4 cm H2O

protective ventilation group

EXPERIMENTAL

Vt = 6ml/kg of PBW, PEEP = 10 and RM if disconnected

Procedure: protective ventilation

Interventions

protective ventilation PROCEDURE

the aim of the intervention is to ovoid Ventilator induced lung injury and inflammatory stress

protective ventilation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia

You may not qualify if:

• Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and BMI \< 16 or \> 35 Kg/m2. They were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.

Sponsors & Collaborators

• Mongi Slim Hospital: lead

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor head of the anesthesiology-ICU departement

Model Details: randomization is decided when patients are schedueld and according a randomization table

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 24, 2017
• Study Start: July 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share