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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
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-Induced Lung Injury focused on measuring protective mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 19, 2017
    Last Updated
    May 23, 2017
    Sponsor
    Mongi Slim Hospital
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    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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