| CTRI Number |
CTRI/2024/01/061055 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing intubation in trachea with two devices in patients with snoring who are risk for difficult intubation using an assessing score |
|
Scientific Title of Study
|
Comparison of awake oral tracheal intubation with flexible bronchoscope versus video laryngoscope in patients at risk of obstructive sleep apnea: A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
APPARI SRI DURGA SIVA PRASAD |
| Designation |
Resident, MD ANAESTHESIA |
| Affiliation |
Hamdard institute of medical sciences and research |
| Address |
Operating theatre, 8th floor, Department of Anaesthesia, Hakeem Abdul Hameed Centenary Hospital, B-block, Jamia Hamdard, Hamdard Nagar, South Delhi,110062
South
DELHI
110062
India |
| Phone |
9494213653 |
| Fax |
|
| Email |
shiva4497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRATIBHA PANJIAR |
| Designation |
MBBS.DA.DNB, ASSOCIATE PROFESSOR |
| Affiliation |
Hamdard institute of medical sciences and research |
| Address |
Operating theatre, 8th floor, Department of Anaesthesia, Hakeem Abdul Hameed Centenary Hospital, B-block, Jamia Hamdard, Hamdard Nagar, south delhi,110062
South
DELHI
110062
India |
| Phone |
9311657822 |
| Fax |
|
| Email |
pratibha.panjiar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
APPARI SRI DURGA SIVA PRASAD |
| Designation |
Resident, MD ANAESTHESIA |
| Affiliation |
Hamdard Institute of medical sciences and research |
| Address |
Operating theatre, 8th floor, Department of Anaesthesia, Hakeem Abdul Hameed Centenary Hospital, B-block, Jamia Hamdard, Hamdard Nagar, south delhi,110062
South
DELHI
110062
India |
| Phone |
9494213653 |
| Fax |
|
| Email |
shiva4497@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hamadard Institute of Medical Sciences and Research and HAHC Hospital |
|
|
Primary Sponsor
|
| Name |
Hamadard Institute of Medical Sciences and Research |
| Address |
Hamdard Institute of Medical Sciences and Research and HAHC Hospital, Hamdard Nagar,110062 |
| 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 |
| APPARI SRI DURGA SIVA PRASAD |
operating rooms |
8th floor, Department of Anaesthesia, B-block, Hakeem Abdul Hameed Centenary Hospital, Hamdard Nagar, south delhi-110062
South
DELHI |
9494213653
shiva4497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-HIMSR |
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 |
Fiberoptic bronchoscope |
Fiber optic bronchoscope is an endoscope used for visualization and Evalution of larynx and trachea transoral and trans nasal intubation in patients undergoing general anaesthesia for scheduled elective procedure |
| Intervention |
kings vision channeled video laryngoscope |
Channeled video laryngoscope is a form of indirect laryngoscopy for visualisation of larynx transorally for intubation in patients undergoing general anaesthesia for scheduled elective procedure, duration 18 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
American society of anesthesiologist grade I-II , Morbidly obese patients, Age>18, Stop bang scoring>3 posted for elective surgery under General Anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to give consent
2. Patient with laryngeal or pharyngeal pathology
3. Patient mouth opening<20mm
4. Lean body< 50kg
5. Pregnant patients
6. Patient with Heart rate<60
7. Patient with local anaesthetic allergy
8. Patient with airway bleeding
9. Patient with fixed flexion deformity |
|
|
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 time to intubation using flexible bronchoscope and video-laryngoscope for awake oral tracheal intubation in patients at risk of OSA. |
Total time for for intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare first attempt success rate between the groups
2. To compare hemodynamic response to intubation between the groups
3. To compare patient discomfort score between the groups
4. To compare intraoperative complications like episodes of desaturation (<93%) and
oropharyngeal mucosal damage |
Hemodynamic response over 15 minutes after intubation
Monitor post-operative complication over 24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
10/01/2024 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shiva4497@gmail.com].
- For how long will this data be available start date provided 24-08-2025 and end date provided 09-05-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
this study is a parallel arm randomized controlled trail, to determine weather kings vision video laryngoscope can be used as alternative to gold standard flexible fiberoptic bronchoscope in patients with at risk of obstructive sleep apnea. the objectives of study are:- 1. to compare total time of intubation 2. to compare 1st attempt success rate 3. to compare intubation attempts between the groups 4. to compare hemodynamic response 5. to compare intraoperative complication like trauma to lips, teeth, mucosa, other soft tissues and postoperative complications like sore throat and cough this trail is conducted in a single center in the operating theatres of HAHC Hospital - Hamdard institute of medical sciences and research |