| CTRI Number |
CTRI/2024/05/067657 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of different equipments to find out the best equipment for awake tracheal intubation. |
|
Scientific Title of Study
|
Evaluation of fiberoptic bronchoscope, c mac videolaryngoscope(D blade) and kingvision videolaryngoscope (channelled blade) for awake tracheal intubation in patients with predicted 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 |
ANUPRIYA SAXENA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Government Institute of Medical Science |
| Address |
House number 9
Type 5
Block F
Gautam Budha University
Greater Noida
Uttar Pradesh
India
OT Complex
Government Institute of Medical Science
Kasna
Greater Noida.201312
Uttar Pradesh
INDIA
Gautam Buddha Nagar
UTTAR PRADESH
210312
India |
| Phone |
9953090044 |
| Fax |
|
| Email |
anupriya.pmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUPRIYA SAXENA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Government Institute of Medical Science |
| Address |
House number 9
Type 5
Block F
Gautam Budha University
Greater Noida
Uttar Pradesh
India
OT Complex
Government Institute of Medical Science
Kasna
Greater Noida.201312
Uttar Pradesh
INDIA
Gautam Buddha Nagar
UTTAR PRADESH
210312
India |
| Phone |
9953090044 |
| Fax |
|
| Email |
anupriya.pmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUPRIYA SAXENA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Government Institute of Medical Science |
| Address |
House number 9
Type 5
Block F
Gautam Budha University
Greater Noida
Uttar Pradesh
India
OT Complex
Government Institute of Medical Science
Kasna
Greater Noida.201312
Uttar Pradesh
INDIA
Gautam Buddha Nagar
UTTAR PRADESH
210312
India |
| Phone |
9953090044 |
| Fax |
|
| Email |
anupriya.pmch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Science
Department of Anesthesia
OT Complex
Kasna
Greater Noida.201312
Uttar Pradesh
INDIA |
|
|
Primary Sponsor
|
| Name |
Government Institute of medical science |
| Address |
Government Institute of Medical science
Department of Anesthesia
OT Complex
Kasna
Greater Noida.201312
Uttar Pradesh
INDIA
Kasna
Greater Noida
India |
| 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 |
| DrAnupriya Saxena |
Government Institute of Medical Science |
Government Institute of Medical Science
Department of Anesthesia
OT Complex
Kasna
Greater Noida.201312
Uttar Pradesh
India
Gautam Buddha Nagar
UTTAR PRADESH |
9953090044
anupriya.pmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS IEC-ECR/1224/Inst/UP/2019 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z533||Procedure converted to open procedure, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Awake tracheal Intubation |
In this study we are comparing three devices i.e fiberoptic bronchoscope,c mac videolaryngoscope,kingvision videolaryngoscope for awake tracheal intubation.
Duration of study will be 1 year. |
| Comparator Agent |
Comparision of fiberoptic bronchoscope,c mac videolaryngoscope , kingvision videolaryngoscope for awake tracheal intubation. |
Comparision of three devices used for awake tracheal intubation .
Duration of study will be 1 year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria-
1 ASA grade I / II.
2 Age between 18-65 years.
3 Patient undergoing surgeries requiring general anaesthesia with intermittent positive pressure ventilation in adult paralyzed patients.
4.Patients with anticipated difficult airway.
|
|
| ExclusionCriteria |
| Details |
⮚ History of
upper gastro-intestinal surgery.
bleeding or clotting abnormalities.
oesophageal trauma ,
oesophageal varices or evidence of upper gastro-intestinal bleed
hiatus hernia, gastroesophageal reflux disease.
⮚ Pregnancy.
⮚ Patient having significant medical diseases in term of cardiac, respiratory, hepatic,
⮚ renal, etc.;
cervical spine pathology
⮚ upper airway pathology;
⮚ Difficult front of neck access.
⮚ who had refused to give consent.
⮚ Risk of regurgitation, and airway surgeries will be excluded
from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the time required for awake intubation using fiberoptic bronchoscope, C-MAC Videolaryngoscope and kingvision videolaryngoscope. |
0MINUTE,5 MINUTE,10MINUTE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate-Number of patients which could be intubated in a single attempt with each of the study device will be recorded |
0MINUTE,5MINUTE,10MINUTE |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study will involve patients classified as American Society of Anesthesiologists (ASA) I-II at our hospital. Written informed consent will be obtained from all participants. The study will enroll patients with undergoing surgery under general anesthesia . The patients will be randomly assigned to three groups Group 1 (n=25): awake tracheal intubation through fiberoptic bronchoscope. Group 2 (n=25): awake tracheal intubation through D blade of cmac videolaryngoscope. Group 3(n=25):Awake tracheal intubation through channelled kingvision videolaryngoscope.
Outcome measures- 1.The time required for awake intubation using fiberoptic bronchoscope, C-MAC Videolaryngoscope and kingvision videolaryngoscope will be noted. Intubation time in seconds was calculated from insertion of C-MAC videolaryngoscope,kingvision laryngoscope or fiberoptic bronchoscope(FOB) in the mouth till confirmation of ETT was done by capnography. 2.First attempt success rate-Number of patients which could be intubated in a single attempt was recorded in each group. 3. Number of attempts needed for intubation- An intubation attempt was considered unsuccessful if the VL was removed from the oral cavity owing to coughing, gagging, or inability to view the vocal cords.Maximum of three attempts were allowed. 4.Laryngeal view -The laryngeal view was assessed by the percentage of glottic opening (POGO) scale./percentage of glottis opening scale. 5.Ease of intubation. 6.Hemodynamic parameters, which include heart rate (HR), mean arterial blood pressure (MABP), and O2% saturation, will be recorded immediately pre-intubation as baseline reading and then at 1 and 5 min post-intubation. 7.Complications or side effects during intubation such as blood clots on the device due to dental or lip trauma and postoperative sore throat will be noted |