| CTRI Number |
CTRI/2016/07/007087 [Registered on: 13/07/2016] Trial Registered Retrospectively |
| Last Modified On: |
13/07/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group 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 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 |
Nishant Sahay |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
112, Type 4 Block 1, AIIMS Residential Area, Khagaul
112, Type 4 Block 1, AIIMS Residential Area, Khagaul
Patna
BIHAR
801105
India |
| Phone |
06122452035 |
| Fax |
|
| Email |
nishantsahay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishant Sahay |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
112, Type 4 Block 1, AIIMS Residential Area, Khagaul
112, Type 4 Block 1, AIIMS Residential Area, Khagaul
Patna
BIHAR
801105
India |
| Phone |
06122452035 |
| Fax |
|
| Email |
nishantsahay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishant Sahay |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
112, Type 4 Block 1, AIIMS Residential Area, Khagaul
112, Type 4 Block 1, AIIMS Residential Area, Khagaul
Patna
BIHAR
801105
India |
| Phone |
06122452035 |
| Fax |
|
| Email |
nishantsahay@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna, Phulwarisharif, Patna, Bihar- 801505 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences 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 |
| NISHANT SAHAY |
AIIMS Patna |
Modular OT, 3rd Floor, 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 |
| AIIMS Patna IEC Human Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
no health disorders. study done to assess superiority of one position over other. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator - no supplemental nasal insufflation during laryngoscopy. |
the standard practice is to give no supplemental nasal oxygen insufflation during intubation. We aim to assess benefits of supplemental oxygen insufflation. |
| Intervention |
Intervention - supplemental nasal oxygen insufflation during laryngoscopy. |
The benefit of oxygen insufflation by nasal route during apnea of laryngoscopy needs to be compared with the usual practice of no nasal oxygen insufflation. The parameters to assess the benefit of this intervention shall be- 1. changes in desaturation safety period and 2. arterial oxygen partial pressure. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
The patients shall be ASA: Grade 1 with Body Mass Index of < 25 Kg/m2 |
|
| ExclusionCriteria |
| Details |
Any lung pathology or respiratory problem
History of any heart disease or cerebrovascular disease
Pregnant patients
Anaemia (haemoglobin < 10gm/dl)
Known difficult airway or modified mallampatti score >2
Smokers.
Any contraindication for nasal prong use eg tumors, fractures, trauma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
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 |
1. Arterial oxygen samples shall be taken thrice. Once before oxygenation is initiated ie time 0, then at 3 minutes of start of study and also after intubation has been confirmed.
2. After giving muscle relaxant ie. roughly 4 minutes after start of study, time taken for hemoglobin oxygen saturation to fall to 92% shall be noted.
3. Time required for saturation to recover to 100% once it has fallen to below 92% shall also be noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recovery of saturation to 100% from 92%, after initiation of positive pressure ventilation with 100% oxygen |
9 minutes |
|
|
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)
|
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="1"
Months="0"
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 in the supine sniffing position, 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% after giving the muscle relaxant and also to assess effect on
partial pressure of oxygen in arterial blood after intubation of this passive nasal oxygen insufflation. The secondary outcome will be compare the recovery time for
oxygen saturation to reach 100% from 92% after initiation of positive pressure ventilation with 100% oxygen. |