search
Back to results

a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries

Primary Purpose

Lung Injury, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
inverse ratio ventilation
Sponsored by
All India Institute of Medical Sciences, Rishikesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Injury, Acute

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-60 years
  • ASA- I and II
  • Patients undergoing laparoscopic upper abdominal surgery

Exclusion Criteria:

  • Significant pulmonary disease
  • Significant cardiac dysfunction
  • BMI>30 kg/m2

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    in this group of patients, inverse ratio ventilation is provided during general anaesthesia

    in this group of patients, conventional ventilation is provided during general anaesthesia

    Outcomes

    Primary Outcome Measures

    change in partial pressure of oxygen from baseline
    Investigators assume that in laparoscopic surgeries inverse ratio ventilation can be used to decrease the airway pressures

    Secondary Outcome Measures

    changes in pulmonary function tests from baseline
    Investigators assume that the pulmonary function tests will be improved as we ventilate with inverse ratio ventilation as a protective lung strategy

    Full Information

    First Posted
    August 14, 2018
    Last Updated
    August 17, 2018
    Sponsor
    All India Institute of Medical Sciences, Rishikesh
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03637530
    Brief Title
    a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries
    Official Title
    A Prospective Randomized Study of Effect if Lung Protective Ventilation by Reducing Airway Pressure During Laparoscopic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    May 2018 (Actual)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    All India Institute of Medical Sciences, Rishikesh

    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
    Carbon dioxide insufflations of abdomen are integral part of laparoscopic operations in minimally invasive surgery era. It does cause splinting effect on diaphragm movement and set it high inside thoracic cavity too. In turn it will be associated with increase in peak and plateau airway pressure during positive pressure ventilation. Inverse ratio ventilation has been shown to improve lung compliance and restrict the peak and plateau airway pressure and should be useful as one of the lung protective ventilation method to improve respiratory outcome in laparoscopy surgery.
    Detailed Description
    Anaesthesiologists have been ventilating patients in the perioperative period with relatively large tidal volumes (10-15 ml/kg ideal body weight) to prevent intraoperative atelectasis. Ventilating patient with large tidal volumes may be a risk factor for development of lung injury.During surgical procedures, both general anesthesia and high tidal volumes may strain non injured lungs and trigger inflammation. High tidal volumes that cause alveolar overstretching can contribute to extra pulmonary organ dysfunction through systemic release of inflammatory mediators. Recently protective lung ventilation strategies has been reported to be useful to reduce the respiratory complications in postoperative period. The use of small tidal volume (Vt), positive end-expiratory pressure (PEEP) and restricting peak airway pressure have shown reduced incidence of ventilation induced lung injury. It has been shown that a small tidal volume (VT) and PEEP can reduce the incidence of postoperative lung dysfunction and improve intraoperative oxygenation. Restricting peak airway pressure can be achieved by inverse ratio ventilation. Minimizing the risk of ventilator-induced lung injury (VILI), improving oxygenation and alveolar recruitment are all advantages of inverse ratio ventilation. However, the potential utility of pressure controlled inverse ratio ventilation (PCIRV) has not been studied in patients undergoing general anaesthesia. Investigators hypothesized that in patients with normal lungs scheduled for general anesthesia, PIV might prevent lung function deterioration and lung morphological alterations. Investiagators aim was to compare the intraoperative protective ventilation strategies on oxygenation/ ventilation and postoperative lung dysfunction and lung injury among patients undergoing laparoscopic upper abdominal surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Injury, Acute

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    in this group of patients, inverse ratio ventilation is provided during general anaesthesia
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    in this group of patients, conventional ventilation is provided during general anaesthesia
    Intervention Type
    Other
    Intervention Name(s)
    inverse ratio ventilation
    Intervention Description
    during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics
    Primary Outcome Measure Information:
    Title
    change in partial pressure of oxygen from baseline
    Description
    Investigators assume that in laparoscopic surgeries inverse ratio ventilation can be used to decrease the airway pressures
    Time Frame
    upto 1 day postoperatively
    Secondary Outcome Measure Information:
    Title
    changes in pulmonary function tests from baseline
    Description
    Investigators assume that the pulmonary function tests will be improved as we ventilate with inverse ratio ventilation as a protective lung strategy
    Time Frame
    upto 3 days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-60 years ASA- I and II Patients undergoing laparoscopic upper abdominal surgery Exclusion Criteria: Significant pulmonary disease Significant cardiac dysfunction BMI>30 kg/m2
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MUKESH TRIPATHI, MD
    Organizational Affiliation
    PROFESSOR AND HOD, ANAESTHESIOLOGY,AIIMS RISHIKESH
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    I would like to share the results of my trail once it gets completed so that the effectiveness of the intervention will be known to others
    Citations:
    Citation
    8. Wang, X.Q., Wang, P.M., Wang, K.G., Jiang, T. and Xu, Z. Pressure-Controlled Inverse Ratio Ventilation during General Anesthesia for Open Abdominal Surgery Improves Postoperative Pulmonary Function. J. Biomedical Science and Engineering, 9, 17-24
    Results Reference
    background

    Learn more about this trial

    a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries

    We'll reach out to this number within 24 hrs