a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries
A Prospective Randomized Study of Effect if Lung Protective Ventilation by Reducing Airway Pressure During Laparoscopic Surgery
interventional
128
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedAugust 20, 2018
August 1, 2018
1.4 years
August 14, 2018
August 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
upto 1 day postoperatively
Secondary Outcomes (1)
changes in pulmonary function tests from baseline
upto 3 days postoperatively
Study Arms (2)
intervention group
EXPERIMENTALin this group of patients, inverse ratio ventilation is provided during general anaesthesia
control group
NO INTERVENTIONin this group of patients, conventional ventilation is provided during general anaesthesia
Interventions
during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics
Eligibility Criteria
You may qualify if:
- Age 18-60 years
- ASA- I and II
- Patients undergoing laparoscopic upper abdominal surgery
You may not qualify if:
- Significant pulmonary disease
- Significant cardiac dysfunction
- BMI\>30 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MUKESH TRIPATHI, MD
PROFESSOR AND HOD, ANAESTHESIOLOGY,AIIMS RISHIKESH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- post graduate,department of Anesthesiology,AIIMS Rishikesh
Study Record Dates
First Submitted
August 14, 2018
First Posted
August 20, 2018
Study Start
December 1, 2016
Primary Completion
May 1, 2018
Study Completion
October 1, 2018
Last Updated
August 20, 2018
Record last verified: 2018-08