| CTRI Number |
CTRI/2024/03/063885 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To study the ease of insertion of tube for providing breaths during anaesthesia using three different technique. |
|
Scientific Title of Study
|
To evaluate the ease of endotracheal intubation using preloaded bougie vs standard bougie vs stylet guided technique in difficult airway patients undergoing elective surgeries. A randomised three arm clinical trial. |
| 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 Suresh Rajkumar |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Aarupadai veedu medical college and hospital. |
| Address |
A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam.
Pondicherry PONDICHERRY 607402 India |
| Phone |
9894723687 |
| Fax |
|
| Email |
bommidisrk@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suresh Rajkumar |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Aarupadai veedu medical college and hospital. |
| Address |
A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam.
Pondicherry PONDICHERRY 607402 India |
| Phone |
9894723687 |
| Fax |
|
| Email |
bommidisrk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pradeesh Johny |
| Designation |
Assistant Professor, Department of Anaesthesiology |
| Affiliation |
Aarupadai veedu medical college and hospital. |
| Address |
A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam.
Pondicherry PONDICHERRY 607402 India |
| Phone |
9003549061 |
| Fax |
|
| Email |
pradeeshjohny@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital kirumpakkam pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and hospital. |
| Address |
Aarupadai veedu medical college and hospital kirumpakkam pondicherry 607402 |
| Type of Sponsor |
Private 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 Dinesh Kumar |
Aarupadai veedu medical college and hospital |
A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam, pondicherry, 607402.
Pondicherry PONDICHERRY |
9176207907
dineshkumarramesh1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee Aarupadai veedu medical college and 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 |
| Comparator Agent |
Preloaded bougie |
Patients undergoing elective surgeries, preloaded bougie was used for the ease of endotracheal intubation in difficult airway, duration is 3 minutes. |
| Comparator Agent |
Standard bougie |
Patients undergoing elective surgeries, standard bougie was used for the ease of endotracheal intubation in difficult airway, duration is 3 minutes. |
| Intervention |
Stylet |
Patients undergoing elective surgeries, stylet was used for the ease of endotracheal intubation in difficult airway, duration is 3 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I and ASA II
2. MPG 3 and 4
3. AGE: 18-60 years
4. Male and female |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to enroll for study
2. Change in the technique of intubation
3. Patients with preoperative sore throat and upper
and lower respiratory tract infection
4. Patients with oropharyngeal pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study is to compare the time taken for intubation with endotracheal tube in difficult airway patients undergoing elective surgery under general anaesthesia. |
2 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts to intubation |
2 minutes |
| Manipulations required to aid intubation. |
3 minutes |
| To assess complications like desaturation, oesophageal intubation and airway trauma during intubation. |
5 minutes |
| To assess incidence of post operative airway related complications like sore throat |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="195" Sample Size from India="195"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/03/2024 |
| 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
|
Successful intubation in the first attempt has been associated with lower incidence of complications. As the number of attempts and the time to intubate increase, injury to airway and risk of desaturation may increase which is potentially life threatening. Various adjuncts and techniques have been devised to facilitate ease of insertion of endotracheal tube during such situations. Tracheal tube introducer, also known as bougie, has been used extensively in difficult airway scenarios to ensure first pass success. Another technique is the use of stylet along with endotracheal tube for intubation. However, it has been noted from previous studies that the usage of bougie leads to less airway trauma as less force needs to be applied during airway manipulation. Preloaded bougie is a modification of the standard technique by which the time taken to introduce endotracheal tube can be minimised. Up to now, only stylet and standard bougie techniques were routinely being used for difficult airway intubation. In this study, we will be using preloaded bougie technique for ease of endotracheal intubation compared with standard bougie and stylet guided techniques in difficult airway. |