| CTRI Number |
CTRI/2024/06/069069 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison between two different rates of oxygen flow through a oxygen delivery device (high flow nasal cannula) in patients who have breathing difficulty with low oxygen levels in their blood. |
|
Scientific Title of Study
|
Effect of two different flow rates with high flow nasal cannula on respiratory parameters in patients with acute hypoxemic respiratory failure:Prospective randomised cross-overstudy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lekshmi S |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences ,Jodhpur. |
| Address |
Department Of Anesthesiology and Critical Care,
3rd floor, Emergency Building, All India Institute Of Medical Sciences, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8281104437 |
| Fax |
|
| Email |
lekshmibshaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar Bhatia |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences ,Jodhpur. |
| Address |
Department of Anaesthesiology and Critical Care,
3rd Floor,Emergency Building ,All India Institute of Medical Sciences, Jodhpur.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pradeep Kumar Bhatia |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Medical Sciences ,Jodhpur. |
| Address |
Department of Anaesthesiology and Critical Care,
3rd Floor ,Emergency Building ,All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
All India Institute of Medical Sciences ,Basni ,Phase 2,Jodhpur,Rajasthan- 342005. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Lekshmi S |
All India Institute of Medical Sciences Jodhpur |
Adult Intensive Care Unit,Department of Anaesthesiology and Critical Care, 3 rd Floor, Emergency Block, Marudhar Industrial Area,2nd phase,Basni,Jodhpur, Rajasthan-342005
Jodhpur
RAJASTHAN |
8619065641
lekshmibshaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Changing HFNC flow rate |
Patients admitted in adult intensive care unit in AIIMS, Jodhpur with Acute hypoxemic respiratory failure who are on HFNC and hemodynamically stable with PaO2/FiO2 ratio less than 300 will be selected for the study. Patients will be randomly assigned with a 1:1 ratio to HFNC 60 group receiving flow at 60L/min initially for 1hour followed by 30L/min for next 1 hour) and HFNC 30 group (HFNC flow at 30L/min initially for 1 hour followed by 60L/min for next 1 hour) with FiO2 adjusted to maintain SPO2 more than 94%.The patients will be observed for one hour and at the end of one hour the study parameters -PCO2 ,PO2, PaO2/FiO2, ROX index , Respiratory Rate, Heart Rate and Mean Arterial Pressure will be recorded.
|
| Comparator Agent |
Same patient will act as his own control since this is a prospective randomized cross over study. |
After 1 hour the flow will be changed to 30L/min in HFNC 60 group and 60L/min in HFNC 30 group and patients will be again observed for one hour. At the end of one hour again the same parameters will be recorded. The change in study parameters will be compared in both the groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All hemodynamically stable patients admitted in Adult Intensive Care Unit in AIIMS,Jodhpur with acute hypoxemic respiratory failure,on High Flow Nasal Cannula with PaO2/FiO2 less than 300 are included in the study. |
|
| ExclusionCriteria |
| Details |
1)Patients with hypoxemic respiratory failure requiring intubation and ventillatory support as per the attending clinician.
2)Patients of chronic respiratory failure.
3)Patients with neuromuscular disorders affecting respiratory muscles and/or diaphragm.
4)Patients with major cardiac, hepatic or renal functions derangement.
5)Pregnant patients.
6)Tracheostomised patients.
7)All the conditions where HFNC is contraindicated like upper airway obstruction, central apnoea, blocked nasal passages or choanal atresia, trauma or surgery to nasopharynx , pneumothorax etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare change in PO2,PCO2 and PaO2/FiO2 at the flow rates of 60 litres/minute and 30 litres/minute. |
After 1 hour of changing HFNC oxygen flow rate. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare incidence of desaturation requiring increase in FiO2.
2)To compare change in ROX index.
3)To compare change in Respiratory Rate, Heart Rate and Mean Arterial Pressure.
|
After 1 hour of changing HFNC oxygen flow rate. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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
|
When using High Flow Nasal Cannula (HFNC), it is important to consider the flow settings, as they have a significant impact on the therapy’s physiological effects.The effect of different oxygen flow rates by HFNC on respiratory physiology has not been adequately studied.We plan this study to compare the clinical response (vitals and arterial blood gas parameters) on two different flows (30 Litres/Minute and 60 Litres/Minute ) of HFNC therapy in patients with acute hypoxemic respiratory failure with a PaO2/FiO2 < 300.Our hypothesis is that there is no difference in arterial blood gas and respiratory parameters at all point intervals between the HFNC flow rates 60 Litres/Minute and 30 Litres/Minute.
Patients admitted in adult intensive care unit in AIIMS, Jodhpur with Acute hypoxemic respiratory failure who are on HFNC and hemodynamically stable with PaO2/FiO2 ratio less than 300 will be selected for the study. The study participants will be recruited after approval from the Institutional Ethics Committee and registration with the Clinical Trials Registry of India(CTRI). Patients will be randomly assigned with a 1:1 ratio to HFNC 60 group (HFNC flow at 60L/min initially for 1hour followed by 30L/min for next 1 hour)and HFNC 30 group (HFNC flow at 30L/min initially for 1 hour followed by 60L/min for next 1 hour) with FiO2 adjusted to maintain SPO2 >94%.The patients will be observed for one hour and at the end of one hour the study parameters -PCO2 ,PO2, PaO2/FiO2, ROX index , Respiratory Rate, Heart Rate and Mean Arterial Pressure will be recorded .After that the flow will be changed to 30L/min in HFNC 60 group and 60L/min in HFNC 30 group and patients will be again observed for one hour. At the end of one hour again the same parameters will be recorded. The change in study parameters will be compared in both the groups. Subsequent treatment will be decided by the attending clinician. The intervention will be labelled as a failure if fall in saturation below 92%, respiratory distress (RR >35) or hemodynamic instability (Fall in MAP of 5% or more) occur during the one hour observation period. The further management of the patient will be done as per the ICU protocol by the treating physician. |