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

Sponsor
All India Institute of Medical Sciences, Rishikesh (Other)
Overall Status
Unknown status
CT.gov ID
NCT03637530
Collaborator
(none)
128
2
22

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: inverse ratio ventilation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Prospective Randomized Study of Effect if Lung Protective Ventilation by Reducing Airway Pressure During Laparoscopic Surgery
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

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

Other: inverse ratio ventilation
during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

  1. change in partial pressure of oxygen from baseline [upto 1 day postoperatively]

    Investigators assume that in laparoscopic surgeries inverse ratio ventilation can be used to decrease the airway pressures

Secondary Outcome Measures

  1. changes in pulmonary function tests from baseline [upto 3 days postoperatively]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • All India Institute of Medical Sciences, Rishikesh

Investigators

  • Study Director: MUKESH TRIPATHI, MD, PROFESSOR AND HOD, ANAESTHESIOLOGY,AIIMS RISHIKESH

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ADABALA VIJAY BABU, post graduate,department of Anesthesiology,AIIMS Rishikesh, All India Institute of Medical Sciences, Rishikesh
ClinicalTrials.gov Identifier:
NCT03637530
Other Study ID Numbers:
    First Posted:
    Aug 20, 2018
    Last Update Posted:
    Aug 20, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2018