CTRI Number |
CTRI/2020/03/023753 [Registered on: 04/03/2020] Trial Registered Prospectively |
Last Modified On: |
27/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effectiveness of nasal prongs in maintaining oxygenation without respiration in patients while giving general anaesthesia |
Scientific Title of Study
|
To evaluate the effectiveness of nasal prongs in maintaining apnoeic oxygenation in patients with simulated cervical spine immobilization |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
10964 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Tanvi Bharadwaj |
Designation |
DNB ANAESTHESIOLOGY |
Affiliation |
NDMC Medical College and Hindu Rao Hospital |
Address |
Department of Anaesthesiology
NDMC Medical College and Hindu Rao Hospital
Malka Ganj New Delhi
Central DELHI 110001 India |
Phone |
8861484626 |
Fax |
|
Email |
tanvibharadwaj4@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Aashish Dang |
Designation |
CMO Anaesthesiology |
Affiliation |
NDMC Medical College and Hindu Rao Hospital |
Address |
Department of Anaesthesiology
NDMC MEDICAL COLLEGE AND HINDU RAO HOSPITAL
Malka Ganj New Delhi
Central DELHI 110007 India |
Phone |
9810710458 |
Fax |
|
Email |
dradang007@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Tanvi Bharadwaj |
Designation |
DNB ANAESTHESIOLOGY |
Affiliation |
NDMC Medical College and Hindu Rao Hospital |
Address |
Department of Anaesthesiology
NDMC Medical College and Hindu Rao Hospital
Malka Ganj New Delhi
Central DELHI 110007 India |
Phone |
8861484626 |
Fax |
|
Email |
tanvibharadwaj4@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology
NDMC Medical College and Hindu Rao Hospital
Malka Ganj
New Delhi
110007 |
|
Primary Sponsor
|
Name |
Department of AnaesthesiologyNDMC Medical College and Hindu Rao Hospital |
Address |
Malka Ganj new Delhi
110007 |
Type of Sponsor |
Government medical college |
|
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 Tanvi Bharadwaj |
NDMC Medical College and Hindu Rao Hospital |
Department of Anaesthesiology
ground floor OT Block
Hindu Rao Hospital
Malka Ganj new Delhi
110007 New Delhi DELHI |
8861484626
tanvibharadwaj4@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics committee of Hindu Rao Hospital |
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 |
Intervention |
Application of nasal prongs |
While giving general anaesthesia, oxygen administered to the patient through nasal prongs by simulating difficult airway by application of MILS and observing vital parameters including saturation and arterial blood gas. |
Comparator Agent |
Oxygen insufflation through nasal prongs during apneoa in test group versus No oxygen insufflation in the control group. |
Oxygen insufflation through nasal prongs during apneoa in test group versus No oxygen insufflation in the control group. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Weight- 50-80 kgs
Height- 150-180cms
ASA grade 1 and 2
Patients undergoing elective surgeries under general anaesthesia
|
|
ExclusionCriteria |
Details |
Patients refusing to participate in study
Body Mass index of <18 and > 30 kg/m2
Patients having nasal obstruction or history of epistaxis.
Patients with anticipated difficult airway.
Patients having present or past history of difficult mask ventilation.
Modified mallampatti score 3 and 4
Patients having present grade 3a/3b or 4 laryngoscopy view(Yentis and Lee’s modification of Cormack and Lehane)
Patient having chronic obstructive pulmonary disease.
Reactive airway or parenchymal disease.
Patient with any anatomical deformity of spine
Patients with history of cardiac, respiratory, renal or hepatic disease
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Wether nasal prongs are effective in maintaining oxygen saturation during periods of apnea in patients with simulated cervical spine immobilisation |
6 minutes or untill the saturation falls till 95% |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the safe apnoea time in group which will be only preoxygenated as compared to group receiving oxygen insufflation through nasal prongs during apneoa in addition to preoxygenation. |
6 minutes or until the saturation falls to 95% |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
10/03/2020 |
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)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Nasal prongs will be applied to evaluate it’s effectiveness in maintaining blood oxygen saturation in case of a extended apnoea due to a difficult airway which will be simulated by application of Manual In Line Stabilization of cervical spine. |