| CTRI Number |
CTRI/2023/07/054931 [Registered on: 07/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of high flow nasal cannula and non invasive ventilation in transport of critically ill patients in hospital |
|
Scientific Title of Study
|
Intrahospital transport of critically ill patients using high flow nasal cannula or non invasive ventilation: A randomised comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna Pratap Mall |
| Designation |
Professor, Department of Anaesthesiology and Critical Care |
| Affiliation |
Eras Lucknow Medical College and Hospita |
| Address |
Department of Anaesthesiology, Eras Lucknow Medical College and Hospital, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9971101762 |
| Fax |
|
| Email |
genesishealthcare121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KRISHNA PRATAP MALL |
| Designation |
Professor |
| Affiliation |
Eras Lucknow Medical College and Hospita |
| Address |
Department of Anaesthesiology,Eras Lucknow Medical College and Hospital, SARFARAZGANJ, HARDOI ROAD
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
genesishealthcare121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raydhi Sharma |
| Designation |
Junior Resident (PG student), Department of Anaesthesiologyt |
| Affiliation |
Eras Lucknow Medical College and Hospita |
| Address |
ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL, SARFARAZGANJ, HARDOI ROAD
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
drraydhisharma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Eras Lucknow Medical College and Hospital Lucknow |
| Address |
ELMCH, SARFARAZGANJ, HARDOI ROAD,LUCKNOW |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KRISHNA PRATAP MALL |
ERA LUCKNOW MEDICAL COLLEGE AND HOSPITAL |
CRITICAL CARE UNIT,ELMCH, LUCKNOW, UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9140283488
genesishealthcare121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ELMCH, Era University, Lucknow |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High flow nasal cannula (HFNC)/ non invasive ventilation (NIV) |
Total duration- 18 months
Patients will be randomized to HFNC or NIV groups.
Group I (intervention) (non-invasive ventilation group) Patients will be connected to a ventilator for conventional NIV with a full-face mask. Positive end-expiratory pressure (PEEP) would initially be adjusted between 2– and 10 cmH2O. The PEEP level or FiO2 (or both) would later on be set to keep the oxygen saturation more than or equal to 92%. The pressure-support level will be set to achieve 6–8 ml/kg expired tidal volume.
Group II(compatartor) (high-flow nasal cannula group) Heated humidified oxygen (31–37°C) will be continuously supplied through binasal large-bore prongs. The initially adjusted oxygen flow rate shall be 50 l/min at an oxygen fraction (FiO2) of 1.0. The FiO2 would then be adjusted to attain SaO2 more than or equal to 92%.
|
| Comparator Agent |
routine ICU care |
ICU medication |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 18 years or above
2) Critically ill patients requiring intra- hospital transport |
|
| ExclusionCriteria |
| Details |
1) Severe respiratory failure requiring immediate tracheal intubation (respiratory frequency 40 times/min, severe hypoxia, severe respiratory acidosis with a ph <7.25, glasgow score <8).
2) A contraindication to NIV (oral and facial trauma, excessive phlegm with poor expectoration ability, hemodynamic instability).
3) Patients with poor short term prognosis (very high risk of death within seven days or receiving palliative care).
4) Pregnant women.
5) Carriers of an implantable defibrillator or pacemaker.
6) Tracheostomized patients.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
1) To determine the effect on oxygenation, by measuring SpO2
during transportation.
2) To determine the need to escalate/de-escalate respiratory
support/ invasive mechanical ventilation after ICU admission.
|
1) during tansportation of patient
2) 5 minutes, 15 minutes, 1 hour, 24 hours, 48 hours after transport.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to record:
1.duration of respiratory support.
2.adverse events during transportation.
3.length of icu stay.
4.length of hospital stay.
5.icu mortality.
6.hospital mortality. |
72 hours after transport, 7 days after transport |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2023 |
| 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
|
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Brief Summary
|
Intra-hospital transfers on NIV/HFC patients are usually made: a) From the emergency department (ED) to the ICU or to another high-intensity ward with experience in handling NIV/HFNC (e.g., The respiratory intermediate care unit), b) Between the ED or the ICU and the radiology department; and c) Between the ED/ICU and specialized care units, such as the endoscopic or hemodynamic unit. However, moving patients from the safety of an intensive care unit (ICU) or other high-intensity care units is associated with an overall complication rate of up to 70% and a mortality rate of 2% . Mechanical ventilation, with its requirement of specific equipment and expertise, might further increase the incidence of transport-related adverse events. Non-invasive mechanical ventilation (NIV) and High Flow Nasal Cannula (HFNC) have been proven to be effective in patients with acute respiratory failure (ARF) of various etiologies. Intra-hospital transfers of patients on NIV have become an increasingly common occurrence. Today, there is a wide range of ventilators offering the opportunity to apply both conventional invasive and non-invasive mechanical ventilation. While unexpected events during the intra-hospital transfer of critical patients receiving conventional ventilation have been extensively reviewed, few recommendations regarding patients receiving NIV and HFNC support are available. The use of NIV and HFNC for the intrahospital transport of patients has not been studied in detail. Thus, the present prospective, randomized, controlled trial compares the efficacy of HFNC versus NIV in the transportation of critically ill patients with acute respiratory failure. |