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
About this trial
This is an interventional prevention trial for Lung Injury, Acute
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
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
NCT ID
NCT03637530
First Posted
August 14, 2018
Last Updated
August 17, 2018
Sponsor
All India Institute of Medical Sciences, Rishikesh
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
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