| CTRI Number |
CTRI/2022/06/043234 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of standard method of pre-oxygenation with heated humidified high flow nasal canula (HHHFNC)for induction of anaesthesia and fiber optic nasal intubation in head and neck cancer surgery. |
|
Scientific Title of Study
|
Comparison of pre-oxygenation with a heated humidified high-flow nasal cannula standard technique for induction of general anaesthesia and fibre-optic nasal intubation in patients undergoing head and neck surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr brajesh kumar ratre |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 160B, first floor, Dr. BRA IRCH, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr brajesh kumar ratre |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 160B, first floor, Dr. BRA IRCH, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr brajesh kumar ratre |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 160B, first floor, Dr. BRA IRCH, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
8696156799 |
| Fax |
|
| Email |
brajesh.ratre@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
| nil |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Research institution |
|
|
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 Brajesh Kumar Ratre |
National cancer Institute |
third floor OT complex, Department of Onco-Anaesthesia and Palliative Medicine, hospital block, Village Badsa, Tah. Badli, Dist Jhajjar, Haryana
Jhajjar
HARYANA |
8696156799
brajesh.ratre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HFNC group
Fisher and paykel AIRVO2 humidification high flow system |
For intervention group, pre-oxygenation will be done using Fisher and paykel AIRVO2 humidification high flow system with flow of 60 litre per minute and FiO2of 1. This will be continuing till the successful Nasotracheal intubation done by using fiber-optic bronchoscope.
Total duration of intervention is 20 minutes. |
| Comparator Agent |
Standard Anaesthesia technique |
pre-oxygenation will be done using standard technique with use of close circuit anaesthesia mask and flow of 15 liter with FiO2 of 1.
Total duration is 20 minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age18 -80 years.
2. Patients undergoing head & neck surgery
3. ASA I, II.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Anticipated difficult airway
3. Mouth opening < 2 finger breadth
4. Patients who feel difficulty during HFNC will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare PaO2 at predefined time points |
Time points will be:
1. Pre induction (room air) ABG
2. 3 minute after pre-oxygenation
3. 90 second after injection rocuronium
4. just after successful intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison in change in PaCO2 & ABG at different predefined time points.
2. Drop in Saturation during intubation
3. Time taken for intubation.
4. Changes in hemodynamic parameters.
5. Comparison in changes in EtCO2and ETO2 after intubation.
|
4 ABG sample will be collected at
1) room air
2) 3 minute post oxygenation
3) 90 second after administration of Rocuronium
4) after successful intubation |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
20/06/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To prevent life-threatening events
during induction of general anaesthesia, pre-oxygenation protocol should extend
the apnea period safely. Fisher
&paykel AIRVO2 humidification high flow system can deliver
warm and humidified oxygen through a specially designed nasal cannula cab be
delivered through high flow nasal cannula at a rate of 60l/min. Several studies
have shown that nasal delivery of humidified oxygen to paralyzed and
anaesthetized patients maintains oxygenation and achieves acceptable carbon dioxide
concentrations.
We hypothesis that an extended apneic period with
pre-oxygenation via the HFNC could be more beneficial to patients undergoing
general anaesthesia and fibre-optic nasal intubation compared with the standard
technique |