| CTRI Number |
CTRI/2016/07/007084 [Registered on: 12/07/2016] Trial Registered Retrospectively |
| Last Modified On: |
12/07/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial to study whether continuous oxygen given through the nose when patient is not breathing during the time when a tube is placed into his neck before surgery for maintaining anesthesia, increases the safety during intubation. |
|
Scientific Title of Study
|
Effect of supplemental oxygen by nasal cannula in 20 degree head up posiition during apnea interval of intubation- a prospective randomized double blind trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishant Sahay |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
112 Type 4 Block 1, AIIMS Residential Area Khagaul
Patna
Dept of Anesthesiology
3rd Floor Mini Hospital Building
AIIMS Patna
Patna
BIHAR
801105
India |
| Phone |
09431184516 |
| Fax |
|
| Email |
nishantsahay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Sahay |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
112 Type 4 Block 1, AIIMS Residential Area Khagaul
Patna
Dept of Anesthesiology
3rd Floor Mini Hospital Building
AIIMS Patna
Patna
BIHAR
801105
India |
| Phone |
09431184516 |
| Fax |
|
| Email |
nishantsahay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Sahay |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
112 Type 4 Block 1, AIIMS Residential Area Khagaul
Patna
Dept of Anesthesiology
3rd Floor Mini Hospital Building
AIIMS Patna
Patna
BIHAR
801105
India |
| Phone |
09431184516 |
| Fax |
|
| Email |
nishantsahay@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Patna |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
AIIMS Patna
Phulwarisharif
Patna |
| 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 Nishant Sahay |
AIIMS Patna |
3rd Floor Modular OT
Mini hospital building
AIIMS Patna
Patna
BIHAR |
9431184516
nishantsahay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Patna Institutional Ethics Committee ( human studies ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oxygen desaturation safety time, apneic insufflation of oxygen |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no oxygen insufflation during apnea of laryngoscopy. |
normally during laryngoscopy no oxygen supplementation is practised. |
| Intervention |
supplemental apneic insufflation of oxygen |
during the apneic period of laryngoscopy, oxygen insufflation using a nasal cannula will be carried out to assess if it increases blood oxygentaion. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
All patients ASA: Grade 1
Body mass index <25 kg/m2
|
|
| ExclusionCriteria |
| Details |
Any lung pathology or respiratory problem
Pregnant patients
Anaemia
modified mallampatti score >3 and/or anticipated difficult airway
history of smoking in the last one week.
Any contraindication for nasal prong use eg tumors, fractures, trauma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Prolongation of time for saturation to come from 100% to 92% during laryngoscopy
2. Increase in arterial oxygen due to supplemental oxygen insufflation
|
8 minutes
5 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Saturation recovery time to 100 %, after positive pressure ventilation with 100% oxygen |
9 minutes |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
02/11/2015 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel
group, trial assessing the effectiveness of supplemental oxygen nasal insufflation during apneic period of laryngoscopy as compared to no oxygen insufflation. The primary outcome measures will be assessing increase in desaturation safety period when arterial saturation comes down to 92% and also to assess effect on partial pressure of oxygen in arterial blood after intubation of this insufflation . The secondary outcomes will
be compare the recovery time for oxygen saturation to reach 100% after initiation of positive pressure ventilation. |