CTRI Number |
CTRI/2023/10/058996 [Registered on: 20/10/2023] Trial Registered Prospectively |
Last Modified On: |
15/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
A PROSPECTIVE COMPARATIVE OBSERVATIONAL STUDY. |
Study Design |
Other |
Public Title of Study
|
To assess whether oxygenation through nasal tube (HFNO) is a better alternative for oxygen administration while you are made unconscious compared to face mask. |
Scientific Title of Study
|
A Comparison Of Efficacy Of Oxygenation Between High Flow Nasal Cannula And Standard Facemask For Preoxygenation And Endotracheal Intubation In Patients Undergoing General Anaesthesia |
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 PATIL GAYATRI CHANDRAKANT |
Designation |
JUNIOR RESIDENT |
Affiliation |
KS HEGDE MEDICAL ACADEMY |
Address |
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 Department of Anaesthesiology
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 Dakshina Kannada KARNATAKA 575018 India |
Phone |
9423652603 |
Fax |
|
Email |
GAYATRI9919@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
Name |
DR ANANDA BANGERA |
Designation |
PROFESSOR |
Affiliation |
KS HEGDE MEDICAL ACADEMY |
Address |
Department of Anaesthesiology
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 Department of Anaesthesiology
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 Dakshina Kannada KARNATAKA 575018 India |
Phone |
9845278880 |
Fax |
|
Email |
ANANDA@NITTE.EDU.IN |
|
Details of Contact Person Public Query
|
Name |
DR ANANDA BANGERA |
Designation |
PROFESSOR |
Affiliation |
KS HEGDE MEDICAL ACADEMY |
Address |
Department of Anaesthesiology
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 Department of Anaesthesiology
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 Dakshina Kannada KARNATAKA 575018 India |
Phone |
9845278880 |
Fax |
|
Email |
ANANDA@NITTE.EDU.IN |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 |
|
Primary Sponsor
|
Name |
NIL |
Address |
NIL |
Type of Sponsor |
Other [NIL] |
|
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 Gayatri Patil |
KS Hegde Hospital |
Department of Anaesthesiology
KS Hegde Medical Academy,
P. O. Nityanandanagar
Deralakatte
Mangluru, Karnataka 575018 Dakshina Kannada KARNATAKA |
9423652603
GAYATRI9919@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: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
nil |
nil |
Intervention |
nil |
nil |
|
Inclusion Criteria
|
Age From |
12.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA I, II
|
|
ExclusionCriteria |
Details |
1.Patients’ or guardians’ refusal to participate
in the study
2.Patients with significant respiratory or cardiac
comorbidities
3.Pregnant ladies
4.Uncooperative patients
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate oxygenation with high flow nasal cannula & facemask oxygenation in terms of SpO2 & EtO2. |
During & immediately after procedure for 5 min |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To assess efficacy of CO2 elimination in terms of EtCO2 level.
2.To find out the patients’ comfort level in accepting these two techniques for preoxygenation.
|
During & immediately after procedure |
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
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)
|
23/10/2023 |
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
|
This
prospective observational comparative study will be conducted after obtaining
approval from the Institutional Ethics Committee. A pre-anesthetic evaluation
with a detailed medical history, systemic examination, and airway examination
will be done and reviewed on the previous day and on the day of surgery. Informed and written consent will be obtained
from the patient and/or the patient’s guardian. Patient will be kept nil by
mouth for 6 hours and premedicated according to standard institutional
protocol. Once the patient is shifted to the operation theatre, standard
preparations such as attaching routine monitoring devices like an electrocardiogram,
pulse oximetry (SpO2), noninvasive blood pressure, and end tidal capnography
will be done. Intravenous fluid will be started after securing a suitable
intravenous cannula. Patients undergoing general endotracheal anesthesia with
oxygenation under a face mask oxygenation will be included under group F and
those with high-flow nasal oxygenation will be included under group H. The
standard and common drugs for induction, muscle relaxation, and inhalational
anesthesia will be followed for all the patients. In the HFNO group,
oxygenation will be performed using a high-flow nasal cannula, with nasal
prongs set at 30 L/min flow of heated and humidified 100% oxygen. In the FMO
group, patients will breathe spontaneously with an appropriate-size standard
facemask connected to a ventilation system with 100% oxygen at 8 L/min. If the
patient doesn’t tolerate HFNO they will be motivated for the same and if they
don’t cooperate even then will be oxygenated with regular facemask technique done
as per the institutional protocol and will be excluded from the study. All of
this will be after 3 minutes of oxygenation, the patient’s airway will be
secured by the anesthesiologist in charge and the technique will be noted.
Number of attempts, time for desaturation (SpO2 <92%), any events occurring
during the process of intubation or any rescue methods if used in case of
desaturation will be noted and the patient will be ventilated as per the
institutional protocol. During intubation, the nasal prongs of the HFNO group
will be left in place to achieve apnoeic oxygenation. In the FMO group, the
facemask will be removed during intubation. The correct placement of the
endotracheal tube will be confirmed by end-tidal capnography, and the nasal
prongs will then be removed from the HFNO group. After intubation, maintenance
of anesthesia will be done according to the standard institutional protocol. |