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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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