Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery
Primary Purpose
Ventilator-Induced Lung Injury, Mechanical Ventilation Complication, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
protective ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator-Induced Lung Injury focused on measuring protective mechanical ventilation
Eligibility Criteria
Inclusion Criteria:
- ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
protective ventilation group
Arm Description
Vt = 8 ml/kg of PBW and PEEP = 4 cm H2O
Vt = 6ml/kg of PBW, PEEP = 10 and RM if disconnected
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03165760
Brief Title
Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery
Official Title
Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
This randomized controlled trial, was approved by the institutional ethics committee of our hospital. Informed consent was obtained from all the participants before randomization. Investigators included 80 patients (40 in each group), ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia.
Patients were not included if they had specially acute respiratory disease, severe asthma or emphysema, sleep apnea syndrome, septic shock and body mass index (BMI) < 16 or > 35 Kg/m2. Participants were excluded in case of serious peroperative anesthetic complications or hemorrhagic shock.
Primary endpoint was 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).
Secondary endpoints for all participants were intra-operative complications (change in SpO2 when dropped less than 90%, hypotension <90 mmHg lasting more than 3 min, need for vasopressor administration, new arrhythmia), postoperative extrapulmonary complications (septic shock, postoperative surgical complications, heart disease complications). Investigators recorded for all participants length of hospital stay and mortality rate were .
Investigators randomly allocated patients before entering to the operating room to:
Control Group (CG): patients ventilated with Vt of 8 ml/kg of predicted body weight (PBW), a low level of PEEP (4 cm H2O) without RM.
Protective Ventilation Group (PVG): patients ventilated with a low Vt of 6 ml/Kg of PBW, a high level of PEEP (10 cm H2O), RMs applied after intubation, before extubation and in case of disconnection from the ventilator.
Other ventilation settings, type of anesthesia, fluid administration and post operative pain management were standardized.
In the postoperative period, investigators daily assessed clinical examination and arterial blood gas if pulse oximetry dropped. For all participants, a chest X ray, blood count creatinine and C reactive protein were done at day 1 and day 3.
Data were presented as means and standard deviation [SD] or frequencies. Statistical analyses were performed using SPSS statistical software version 20.0. A p-value of 0.05 was considered significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Induced Lung Injury, Mechanical Ventilation Complication, Postoperative Complications
Keywords
protective mechanical ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomization is decided when patients are schedueld and according a randomization table
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Vt = 8 ml/kg of PBW and PEEP = 4 cm H2O
Arm Title
protective ventilation group
Arm Type
Experimental
Arm Description
Vt = 6ml/kg of PBW, PEEP = 10 and RM if disconnected
Intervention Type
Procedure
Intervention Name(s)
protective ventilation
Intervention Description
the aim of the intervention is to ovoid Ventilator induced lung injury and inflammatory stress
Primary Outcome Measure Information:
Title
Postoperative pulmonary complications
Description
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)
Time Frame
Postoperative pulmonary complications within the first 7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I or II, planned for open abdominal surgery lasting more than 2 hours under general anesthesia
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Protective Mechanical Ventilation and Risk of Postoperative Complications in Abdominal Surgery
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