| CTRI Number |
CTRI/2024/09/074397 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intubation] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the use of a bougie with the use of a nasogastric tube to help in nasotracheal intubation. |
|
Scientific Title of Study
|
Nasotracheal intubation over a bougie vs use of nasogastric tube to facilitate intubation. A prospective 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 |
Dr Phibahun Shisha War |
| Designation |
Post Graduate Resident |
| Affiliation |
Kidwai Memorial Institute of Oncology, Bengaluru |
| Address |
Department of Anaesthesia
Room no.105
Dr MH, Marigowda Road,Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
7630927482 |
| Fax |
|
| Email |
phibashishawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashidhar GS |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology, Bengaluru |
| Address |
Department of Anaesthesia
Room no. 105
Dr MH, Marigowda Road,Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9008028611 |
| Fax |
|
| Email |
drshashi_2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashidhar GS |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology, Bengaluru |
| Address |
Department of Anaesthesia
Room No. 105
Dr MH, Marigowda Road,Lakkasandra, Hombegowda Nagar, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9008028611 |
| Fax |
|
| Email |
drshashi_2007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute Of Oncology,
Dr MH, Marigowda Road,Lakkasandra, Hombegowda Nagar, Bengaluru, Karnataka 560029,India, |
|
|
Primary Sponsor
|
| Name |
Dr Phibahun Shisha War |
| Address |
Room no. 105
Kidwai Memorial Institute of Oncology, Dr MH, Marigowda Road, Lakkasandra, Hombegowda Nagar, Bengaluru,Karnataka, 560029, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Phibahun Shisha War |
Kidwai Memorial Institute of Oncology, Bengaluru |
Department of Anaesthesia, Room No. 105
Dr MH, Marigowda Road, Lakkasandra, Hombegowda Nagar, Bengaluru.
Bangalore
KARNATAKA |
7630927482
phibashishawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee, Kidwai Memorial Institute Of Oncology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1-Bougie
|
Nasotracheal intubation guided by bougie |
| Comparator Agent |
Arm 2- Nasogastric tube
|
Nasotracheal intubation guided by nasogastric tube |
| Comparator Agent |
Arm 3- Without bougie or nasogastric tube |
Nasotracheal intubation without guidance of bougie or nasogastric tube |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgery with nasotracheal intubation under general anesthesia.
2.Age 18 to 65 years.
3.American Society of Anesthesiologists Grade I and II patients.
4.Patients consenting for the study.
5.Modified Mallampati Grading Grade I and II
|
|
| ExclusionCriteria |
| Details |
1.Patients refusal to consent.
2.American Society of Anesthesiologists Grade III and IV patients.
3.Difficult Airway. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Ease of intubation |
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to intubation
2.First pass success
3.Nasopharyngeal trauma post intubation |
At the time of intubation. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
This is a prospective, randomized controlled study comparing the different techniques of nasotracheal intubation over 2 years in 75 patients undergoing elective surgeries requiring nasotracheal intubation. Arm1- bougie guided nasotracheal intubation. Arm 2- nasogastric tube guided nasotracheal intubation. Arm 3- control group( no bougie or nasogastric tube). The primary outcome measures the ease of intubation( navigability of bougie or nasogastric tube through nasal pathway). The secondary outcomes include time to intubation( time from first entrance of bougie or nasogastric tube or tracheal tube into nasal cavity to presence of end tidal CO2), first pass success( frequency of successful intubation in first attempt) and post intubation bleeding(evaluation under direct laryngoscopy).
|