| CTRI Number |
CTRI/2019/12/022214 [Registered on: 02/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing different techniques to find out how roomy the nose is to pass a tube through the nose into the windpipe for anaesthesia |
|
Scientific Title of Study
|
Comparison of preoperative ultrasonographic technique, preoperative MRI/CT scan imaging and digital examination technique for nostril selection prior to nasotracheal intubation: A randomised controlled trial |
| Trial Acronym |
USIFOD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Trial is not registered with any other registry |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
shah.shagun@rgcirc.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
shah.shagun@rgcirc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
shah.shagun@rgcirc.org |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and research Centre; Sector -5; Rohini; Delhi-110085 |
|
|
Primary Sponsor
|
| Name |
Dr Shagun Bhatia Shah |
| Address |
H.No-174-175; ground floor ;pocket -17; sector-24; Rohini- Delhi-110085 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Shagun Bhatia Shah |
Rajiv Gandhi Cancer Institute and Research Centre |
Operation Theatre no:6;Department of Anaesthesia;Operation Theatre Division;Third Floor ;Old Building;Sect or-5;Rohini;Delhi-11008 5
North West
DELHI |
9891769779
shah.shagun@rgcirc.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Digital examination |
Palpation of nostrils with gloved lubricated index finger Frequency: Once
1 min before induction |
| Intervention |
Fibreoptic bronchoscopic examination |
Flexible fibreoptic bronchoscopic examination of the nasal cavity in the operation theatre
Frequency: Once
One min after induction |
| Intervention |
Magnetic resonance imaging scan |
Display and scrutiny of pre-existing magnetic resonance imaging plates of the nasal region in the view box of the operation theatre
Frequency: Once
3 min before induction |
| Intervention |
Ultrasonographic examination of nose |
Point of care ultrasound examination of nostrils
Frequency:Once
2 min before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Weight 40-80kg
Patients scheduled to undergo nasotracheal intubation for head and neck oncosurgery
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Pre-existing coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of introduction of nasotracheal tube into the selected nostril |
At the time of nasotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of intubation attempts |
At the time of nasotracheal intubation |
| Bleeding and trauma |
At the time of nasotracheal intubation |
| Use of smaller sized nasotracheal tube |
At the time of nasotracheal intubation |
| Endotracheal tube cuff rupture |
Immediately after nasotracheal tube insertion on cuff inflation |
| Ease of nasogastric tube insertion |
At the time of nasogastric tube insertion (1 min after nasotracheal tube insertion) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, interventional, four-arm, single centric randomised controlled study comparing the ease of intubation between four techniques of determining nasal patency in 120 patients undergoing head and neck oncosurgery requiring nasal intubation. The patients shall be randomly allocated into one of the four groups (Group D: Digital group; Group I: Imaging group; Group S: Sonography group and Group F: Fiberoptic bronchoscopy group). The primary outcome measures would be ease of nasotracheal tube insertion through the selected nostril into the oral cavity. The secondary outcome measures pertaining to the nasotracheal tube would be the number of attempts at intubation, use of a smaller sized endotracheal tube and complications like bleeding/ tissue trauma and endotracheal tube cuff rupture noted immediately after nasotracheal intubation. Another secondary outcome measure would be the ease of nasogastric tube insertion. |