| CTRI Number |
CTRI/2025/05/086902 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study ease of putting tube in windpipe of patients using two different techniques |
|
Scientific Title of Study
|
Comparison of ease of awake intubation using traditional fibreoptic bronchoscope assisted versus hybrid technique in patients with difficult airway. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahesh Madhu |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute of Medical sciences and research institute, Kochi |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical sciences and Research institute.
Ponekkara
Edapally PO
Thiruvananthapuram
KERALA
682041
India |
| Phone |
9207109602 |
| Fax |
|
| Email |
maheshmadhuuae@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Rajan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of Medical sciences and research institute, Kochi |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical sciences and Research institute.
Ponekkara
Edapally PO
Ernakulam
KERALA
682041
India |
| Phone |
9447464652 |
| Fax |
04842802020 |
| Email |
suneil71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahesh Madhu |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute of Medical sciences and research institute, Kochi |
| Address |
Department of Anaesthesiology
Amrita Institute of Medical sciences and Research institute.
Ponekkara
Edapally PO
Thiruvananthapuram
KERALA
682041
India |
| Phone |
9207109602 |
| Fax |
|
| Email |
maheshmadhuuae@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences, Kochi,682041, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical sciences and Research Institute |
| Address |
Amrita institute of medical sciences and Research institute, AIMS Ponekkara PO, Kochi 682041, Kerala, India |
| 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 Mahesh Madhu |
Amrita institute of Medical science |
Department of Anaesthesiology,
AIMS Ponekkara PO,Kochi 682041
Ernakulam
KERALA |
9207109602
04842802020
maheshmadhuuae@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
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 |
Fibreoptic intubation |
In one group of patients intubation will be done using fibreoptic bronchoscope assistance. |
| Intervention |
Hybrid intubation |
In one group of patients intubation will be done using Fibreoptic bronchoscope with videolaryngoscope assistance immediately after airway is anesthetized. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Surgical patients with difficult airway with POGO score of 0% on awake check laryngoscopy using C MAC videoscope
2. Male and female patients
3. Age 18-70 years
4.American Society of Anesthesiologists (ASA) physical status 1 to 3 |
|
| ExclusionCriteria |
| Details |
1. Patients with coagulopathies
2. Patients on betablockers
3.Patients with oral/nasal tumors
4. Patients with restricted mouth opening
|
|
|
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 will be comparison of time taken to for awake intubation in patients with difficult airway using fiberoptic bronchoscope assisted traditional method versus hybrid technique.
|
Time taken for intubation will be noted immediately after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of intubation, number of attempts at intubation, incidence of trauma, patient comfort & hemodynamic changes |
Ease of intubation & number of attempts at intubation will be noted immediately after intubation. Incidence of trauma & patient comfort will be noted 1 minute after intubation. Heart rate & blood pressure will be noted at 1,3,5 & 10 min after intubation. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/05/2025 |
| 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 Yet Recruiting |
| 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
|
The proposed study is a prospective observational study. There will be two groups of which one will be intubated using fibreoptic bronchoscope assisted traditional method while the other group will be intubated using the hybrid technique with a combination of C-MAC videolaryngoscope and fibreoptic bronchoscope. The primary objective of the study will be comparison of time taken to for awake intubation in patients with difficult airway using fibreoptic bronchoscope assisted traditional method versus hybrid technique. The ease of intubation, the number of attempts at intubation, incidence of trauma, incidence of hypotension, bradycardia, desaturation to <95% requiring intervention, patient comfort and the hemodynamic changes during intubation will also be assessed. |