| CTRI Number |
CTRI/2020/07/026375 [Registered on: 06/07/2020] Trial Registered Prospectively |
| Last Modified On: |
30/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which is better for intubation for giving anaestheisa in terms of lesser time in patient undergoing spine surgery of the neck region? Endotracheal tube with stylet or bougie guided. |
|
Scientific Title of Study
|
To assess the time taken for successful intubation using bougie vs endotracheal tube and stylet in patients with cervical immobilization undergoing cervical spine surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DNamratha |
| Designation |
Junior resident |
| Affiliation |
PGIMER,Chandiagrh |
| Address |
Dept of anaesthesia and intensive care
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722756500 |
| Fax |
|
| Email |
namrathareddydr1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amarjyoti Hazarika |
| Designation |
Associate Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Dept of anaesthesia and intensive care
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722920016 |
| Fax |
|
| Email |
amarjyoti28@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amarjyoti Hazarika |
| Designation |
Associate Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Dept of anaesthesia and intensive care
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
01722920016 |
| Fax |
|
| Email |
amarjyoti28@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Dept of anaesthesia and intensive care
PGIMER
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Amarjyoti Hazarika |
PGIMER |
room no 1; Dept of anaesthesia and intensive care,
PGIMER
Chandigarh
Chandigarh
CHANDIGARH |
01722920016
amarjyoti28@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W178||Other fall from one level to another, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bougie guided |
bougie guided endotracheal intubation |
| Intervention |
Stylet guided ETT |
comparing ETI using bougie and ETI with stylet in cervical immobilized patients in regards to time to successful intubation.The duration that will be measured will be the time taken from laryngoscope reaching the epiglottis to successful intubation of the ETT tube and appearance of first capnography waves on the monitor |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group: 18 yrs and Above
2.ASA Status: ASA I and II
3.Patients with cervical spine immobilization
with a collar or with traction
4.Undergoing cervical spine surgery
5.Using a Video laryngoscope to visualize the cords.
|
|
| ExclusionCriteria |
| Details |
1.ASA III or IV Patients
2.AGE <18 YRS
3.Mouth opening of less than three fingers
4.Pregnant women
5.Patients with known distortion of the upper airway or glottic structures (eg: angioedema, epiglottitis, laryngeal mass or malignancy)
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to successful intubation facilitated by the bougie vs the ET with stylet using video-laryngoscope |
Baseline, at neutral position.
point of insertion of the ETI through the glottis aperture.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First attempt successful intubation, overall success rate of ETI, Cervical spine motion using fluoroscopy, CL grade and rate of complications in the form of desaturation, bleeding, broken teeth, trachea-bronchial perforation, pneumothorax, vocal cord injury would be assessed as secondary outcomes |
Baseline, at neutral position.
point of insertion of the ETI through the glottis aperture.
|
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
22/07/2020 |
| 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="6"
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
|
There are studies which have compared the intubation success between bougie and stylet in varied group of patients including difficult airways both actual and simulated, but there is paucity of literature comparing ETI using bougie and ETI with stylet in cervical immobilized patients. We hypothesized that time to successful intubation would be less with Bougie than ET with stylet. |