| CTRI Number |
CTRI/2021/03/031855 [Registered on: 10/03/2021] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 different technique of tube insertion in windpipe under local anesthesia and sedation. |
|
Scientific Title of Study
|
Comparison of awake nasotracheal intubation using flexible Fibre-optic bronchoscope versus D blade CMAC Video-laryngoscope in patients having anticipated difficult airway under topical local anaesthesia and dexmedetomidine infusion. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aritra Kundu |
| Designation |
Junior Resident (Post graduate trainee) |
| Affiliation |
All Indian Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5013, 5th floor, Teaching block, Department of Anaesthesiology, Pain Medicine and Critical Care
All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
989991524 |
| Fax |
|
| Email |
karitra52@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Patel |
| Designation |
Assistant Professor |
| Affiliation |
All Indian Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5013, 5th floor, Teaching block, Department of Anaesthesiology, Pain Medicine and Critical Care
All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Patel |
| Designation |
Assistant Professor |
| Affiliation |
All Indian Institute of Medical Sciences, New Delhi |
| Address |
Room no. 5013, 5th floor, Teaching block, Department of Anaesthesiology, Pain Medicine and Critical Care
All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine & Critical Care,
All India Institute of Medical Sciences, Ansari nagar, New delhi- 110029
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Room no. 5013, 5th floor, Teaching Block, Department of Anaesthesiology, Pain Medicine & Critical Care,
All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029
|
| 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 |
| Dr Aritra Kundu |
All India Institute of Medical Sciences |
Room no 5013, 5th floor teaching block,Department of Anaesthesiology, Pain Medicine & Critical Care,
All India Institute of Medical Sciences.
Ansari Nagar, New Delhi
South West
DELHI |
9869991524
karitra52@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commitee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Awake nasotracheal intubation by D-blade CMAC videolaryngoscopy |
under 4% lignocaine nebulisation with 5-6 l/min oxygen and Lignocaine 10% pump spray will be used by applying two puffs on tonsillar pillars and back of the throat. the patient will be sedated using a loading dose of 1mcg/kg of dexmedetomidine over 10 min followed by infusion at a rate of 0.4 mcg/kg/hr. After adequate sedation is achieved, D-blade CMAC videolaryngoscope will be inserted to aid in intubation. If there is difficulty in negotiating the endotracheal tube, a bolus of injection propofol will be given at the dose of 0.5 mg/kg. |
| Intervention |
Awake nasotracheal intubation by fibre-optic bronchoscopy |
under 4% lignocaine nebulisation with 5-6 l/min oxygen and Lignocaine 10% pump spray will be used by applying two puffs on tonsillar pillars and back of the throat. the patient will be sedated using a loading dose of 1mcg/kg of dexmedetomidine over 10 min followed by infusion at a rate of 0.4 mcg/kg/hr. After adequate sedation is achieved, fibre optic bronchoscope will be inserted to aid in intubation. If there is difficulty in negotiating the endotracheal tube, a bolus of injection propofol will be given at the dose of 0.5 mg/kg. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
mouth opening >1.5cm
ASA Status I-III
Elective surgery requiring nasotracheal intubation
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Severe bradycardia (heart rate <50/min)
Any type of atrioventricular block in electrocardiogram (ECG)
Heart failure
Base of skull fracture
Emergency surgery
Thrombocytopaenia or coagulopathy contraindicated to nasal intubation.
Patient with nasal pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the awake nasotracheal intubation time between the fibreoptic bronchoscope group and D-blade CMAC videolaryngoscope group. |
preoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The intubation score for both the groups
To evaluate the first attempt success rate
To evaluate overall success rate
POGO (Percentage of Glottic Opening) score in Group C only.
Adverse events during intubation
Haemodynamic changes during intubation
Anaesthetist’s satisfaction score (Numerical score)
Patient’s satisfaction score
|
peroperative to post operative 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/09/2021 |
| Date of Study Completion (India) |
20/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
this study is a randomized study to compare awake nasotracheal intubation using flexible Fibre-optic bronchoscope versus D blade CMAC Video-laryngoscope in patients having anticipated difficult airway under topical local anaesthesia and dexmedetomidine infusion. |