| CTRI Number |
CTRI/2023/01/049207 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
18/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
High Frequency Nasal Oxygenation for providing oxygen therapy after abdominal surgeries |
|
Scientific Title of Study
|
A randomised controlled study to evaluate and compare the
efficacy of High Frequency Nasal Oxygenation with conventional
oxygen therapy for postoperative oxygenation in patients
undergoing exploratory laparotomies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POONAM |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES, GTB HOSPITAL, DELHI 110095 |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, UNIVERSITY COLLEGE OF MEDICAL SCIENCES, GTB HOSPITAL, DELHI 110095
East DELHI 110095 India |
| Phone |
9873937636 |
| Fax |
|
| Email |
poonamsehrawat8800@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
POONAM |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES, GTB HOSPITAL, DELHI 110095 |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, UNIVERSITY COLLEGE OF MEDICAL SCIENCES, GTB HOSPITAL, DELHI 110095
DELHI 110095 India |
| Phone |
9873937636 |
| Fax |
|
| Email |
poonamsehrawat8800@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr GEETANJALI T CHILKOTI |
| Designation |
Professor |
| Affiliation |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES, GTB HOSPITAL, DELHI 110095 |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, UNIVERSITY COLLEGE OF MEDICAL SCIENCES, GTB HOSPITAL, DELHI 110095
East DELHI 110095 India |
| Phone |
9711210772 |
| Fax |
|
| Email |
geetanjalidr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and GTB Hospital, Delhi |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, UNIVERSITY COLLEGE OF MEDICAL SCIENCES, GTB HOSPITAL, DELHI 110095 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poonam |
UNIVERSITY COLLEGE OF MEDICAL SCIENCES AND GTB HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, Second floor, ICU block East DELHI |
09873937636
poonamsehrawat8800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR), UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI, DELHI 110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL OXYGEN THERAPY |
Patients receive COT via simple face mask in the postoperative period for 24 hrs. |
| Intervention |
high flow nasal oxygen therapy |
Patients receive HFNO via HFNC in the postoperative period for 24 hrs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Consenting patients scheduled for exploratory abdominal surgeries under general anaesthesia with ARISCAT score ≥26 i.e.moderate to high risk. |
|
| ExclusionCriteria |
| Details |
Chronic obstructive pulmonary disease or asthma causing limitations in everyday activities, heart failure with clinical symptoms equivalent to NYHA functional classification > 2, restrictive lung disease with > 20% reduction in total lung capacity, BMI>40 kg/m2, Inability to comprehend oral or written information
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PaO2/FiO2
|
At the end of 24th hr between the two groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PaO2/FiO2, PaCO2, SaO2/FiO2
Patient satisfaction, Chest X ray proven PPC, Proportion of PPCs; Proportion of acute hypoxemic respiratory failure; Reintubation rate or NIV use; Complications associated with intervention |
PaO2/FiO2, PaCO2 and SaO2/FiO2 at the end of 2nd hr, 6th hr, 12th and 24th hr
Patient satisfaction at the end of day 1,
Chest X ray proven PPC at the end of day 3 |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative pulmonary
complication (PPC) is a common complication after surgery resulting in
increased morbidity, mortality and prolonged hospital stay. Post operative
hypoxaemia has been reported in 10-50% of patients after surgery and in
abdominal surgeries it has been reported as high as 40%. To prevent this,
oxygen therapy has been a norm after surgery. Recently, high-flow nasal cannula
(HFNC) has been evaluated for this indication and found to be superior to
conventional oxygen therapy (COT) in cardiac and thoracic surgeries, obese patients,
critically ill patients and in neonates. However, its use in specific patient
subpopulation still needs to be investigated.This study is undertaken to
evaluate and compare the efficacy of High Frequency Nasal Oxygenation with
conventional oxygen therapy for postoperative oxygenation in patients
undergoing exploratory laparotomies for prevention of postoperative pulmonary
complications. The
present RCT includes patients aged 18-65 years, scheduled for exploratory
abdominal surgeries under GA with ARISCAT score ≥26 i.e., moderate to high
risk. Patients with chronic obstructive
pulmonary disease or asthma causing limitations in everyday activities, heart
failure with clinical symptoms equivalent to NYHA functional classification
> 2, restrictive
lung disease with > 20% reduction in total lung capacity, BMI>40
kg/m2 or inability
to comprehend oral or written information will be excluded
After adequate reversal of neuromuscular blockade and removal of
endotracheal tube, patients in both the group will be shifted to postoperative
room and depending on the group allocation, they will receive either COT or
HFNC. Patients in High flow nasal
oxygenation (HFNO) group will receive a flow rate of 35 to 60 L/min and FiO2
will be titrated (from 45% to 100%) by the treating clinician to maintain a
peripheral oxygen saturation (SpO2) of 95% or more. The COT group will receive
oxygen via simple facemask with oxygen flow titrated (from 45% to 100%) by the
bedside clinician to maintain a SpO2 of 95% or more. In COT group, each
additional litre/min of oxygen adds an FiO2 of 0.4 for the first 3liters and
FiO2 of 0.3 for every litre thereafter. Arterial blood samples will be
collected after extubation at various designated time points i.e. after 2nd hr, 6th hr, 12th and 24th hr.
Non-invasive blood pressure (NIBP), Heart rate (HR) will be recorded for 2 hrs.
The primary outcome is to determine PaO2/FiO2 at the end of 24th hr between the
two groups and secondary outcomes are PaO2, SaO2/FiO2, PaCO2, patient
satisfaction, chest X ray proven PPCs, proportion of PPCs and acute hypoxemic
respiratory failure, proportion of reintubation or non-invasive ventilation
(NIV) use and complications.
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