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CTRI Number  CTRI/2023/10/058352 [Registered on: 05/10/2023] Trial Registered Prospectively
Last Modified On: 04/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   this study will compare two breathing assisting devices HFNC and NIV in the treatment of acute heart failure patients 
Scientific Title of Study   A non-inferiority, randomized, controlled trial comparing high flow nasal cannula to non-invasive ventilation in patients with acute cardiogenic pulmonary edema in emergency room 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadananda Barik 
Designation  Associate professor 
Affiliation  AIIMS Bhubaneswar 
Address  Faculty room, Department of Trauma and Emergency, AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar PIN 751019
Khordha
ORISSA
751019
India 
Phone  07682959066  
Fax    
Email  tem_sadananda@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Sadananda Barik 
Designation  Associate professor 
Affiliation  AIIMS Bhubaneswar 
Address  Faculty Room, Department of Trauma and emergency, AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar PIN 751019
Khordha
ORISSA
751019
India 
Phone  07682959066  
Fax    
Email  tem_sadananda@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Amal Ravi 
Designation  Junior resident(Academic) 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Trauma & Emergency, AIIMS Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9544054828  
Fax    
Email  amalravi98@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS BHUBANESWAR 
Address  Faculty room, Department of Trauma and Emergency, Sijua, Patrapada, Bhubaneswar, PIN-751019 
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 Sadananda Barik  AIIMS BHUBANESWAR  Faculty room,department of Trauma and Emergency, AIIMS BBSR Sijua, Patrapada,Bhuabeswar
Khordha
ORISSA 		 7682959066

tem_sadananda@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,, All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  high flow nasal cannula(HFNC) oxygen therapy  Patients with acute cardiogenic pulmonary edema will be instituted HFNC therapy.The HFNC group will receive therapy starting at a flow rate of 35L/min (at 35-37 degrees Celsius), which can be increased up to 60L/min, to achieve target SpO2 of 94-96%. Patient data such as Respiratory rate,Heart rate,SpO2,Blood pressure,Level of dyspnea(Assessed by Modified Borg’s dyspnea scale),Arterial blood gas analysis, B-lines profile on lung ultrasound, oxygen flow rate of HFNC to be recorded at 1hour,4 hour,12hours,24 hours,36hours, 48 hours and 72 hours after starting of therapy. If the targets are met, weaning of the intervention can be initiated and continued as long as clinical improvement is maintained, under the discretion of the treating physicians. Duration of therapy is 72hours. 
Comparator Agent  non invasive ventilation(NIV) therapy  Patients with acute cardiogenic edema will be instituted Non-invasive ventilation. NIV will be initiated with pressures set at Pressure support(PS)of 4 cmH2O and Positive End Expiratory Pressure (PEEP) at 4 cmH2O, FiO2 at 1.0, and PS will be titrated to achieve desired tidal volume of 6-8ml/kg of body weight and PEEP will be titrated to achieve target SpO2 of 94-96%.Patient data such as Respiratory rate,Heart rate,SpO2,Blood pressure,Level of dyspnea(Assessed by Modified Borg’s dyspnea scale),Arterial blood gas analysis, B-lines profile on lung ultrasound, tidal volume in ventilator to be recorded at 1hour,4 hour,12hours,24 hours,36hours, 48 hours and 72 hours after starting of therapy.If the targets are met, weaning of the intervention can be initiated and continued as long as clinical improvement is maintained, under the discretion of the treating physicians. Duration of therapy is 72hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients of age 18 to 80years, presenting to Emergency department with acute dyspnea, with clinical, radiological and ultrasonography evidence of acute cardiogenic pulmonary edema.
2.The patient must have substantial breathing difficulties that necessitate the use of non-invasive ventilation techniques to provide relief which is assessed by following criteria
2.1 Respiratory rate(RR)>25 breaths/min with signs of respiratory distress such as, use of accessory muscles of respiration
2.2 SpO2<90% on room air,PaO2/FiO2<200 with maximum oxygen supplementation by conventional methods. 
 
ExclusionCriteria 
Details  1.Patients needing immediate endotracheal intubation due to severe respiratory distress and inability to maintain adequate oxygenation(SpO2<90% with oxygen supplementation)
2.Patients with cardiac or respiratory arrest
3.Patients with hemodynamic instability
4.Patients with a low Glasgow Coma Scale score <10
5.Patients having excessive respiratory secretions
6.Agitated/Non-cooperative patients
7.Patients associated with pulmonary diseases like AECOPD/pneumonia/interstitial lung disease/pneumothorax/lung metastasis/miliary TB
8.Patients with fluid overload due to chronic kidney disease
9.Patients with acute myocardial infarction
10.Patients with do-not-intubate order
11.Patients with home NIV support
12.Pregnant patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome:Intubation rate within 72 hours after the initiation of study intervention

Indication of Intubation
pH less than 7.1 with progressively increasing paCO2, uncontrolled hypoxia defined as paO2 less than 50 despite maximal therapy, serious alterations in consciousness, cardiac arrest or respiratory rate less than 8 or more than 45 per minute or any other life threatening condition. 		 Patient data such as Respiratory rate,Heart rate,SpO2,Blood pressure,Level of dyspnea, B-lines profile on lung ultrasound, arterial blood gas analysis,Ventilator parameters like Oxygen flow(in HFNC),Pressure support and PEEP(in NIV),FiO2 and Tidal Volume to be assessed at 1hour,4 hours,12hours,24 hours,36hours, 48 hours and 72 hours after starting of therapy.

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in PaO2,PaCO2,pH,respiratory rate,heart rate.
2.To evaluate patient reported outcomes such as dyspnea,comfort
3.To compare the length of hospital stay & mortality rates in patients treated with HFNC versus NIV 		 0mins,1hour,4hours,12hours,24hours,48hours,72hours 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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)   15/10/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Both non invasive ventilation(NIV and High flow nasal cannula(HFNC))have been found to improve oxygenation, decrease work of breathing and improve ventilation in acute pulmonary edema patients. As compared to conventional therapy, there is no head-to-head trial comparing HFNC and NIV therapy in acute cardiogenic pulmonary edema patients.So this study will show whether HFNC is equally efficacious to NIV or not. 
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