| CTRI Number |
CTRI/2024/07/070966 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| 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 two submental intubation technique during facial fracture fixation surgery |
|
Scientific Title of Study
|
Comparison of Modified Altemirs technique with Seldingers technique of submental intubation for airway management in patients undergoing Complex maxillofacial fractures fixation surgery A Randomised Interventional Comparative Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geeta Singariya |
| Designation |
Senior Professor |
| Affiliation |
Dr S N Medical College Jodhpur |
| Address |
Main operation theater complex first floor
Department of Anaesthesia
MDM Hospital
Dr S N Medical collage Jodhpur RAJASTHAN 342001
India
123 Vaishali avenue Jhanwar road Jodhpur
Jodhpur
RAJASTHAN
342008
India |
| Phone |
09414084584 |
| Fax |
|
| Email |
geetamanojkamal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika |
| Designation |
Junior Resident |
| Affiliation |
Dr S N Medical College Jodhpur |
| Address |
Main OT Complex First Floor Department of Anaesthesia MDM hospital Dr S N medical collage Jodhpur Rajasthan 342001
Main OT Department of Anaesthesia First Floor MDM hospital Dr S N medical collage Jodhpur Rajasthan 342001
Jodhpur
RAJASTHAN
342008
India |
| Phone |
7030162595 |
| Fax |
|
| Email |
monikamalik242@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Singariya |
| Designation |
Senior Professor |
| Affiliation |
Dr S N medical collage Jodhpur |
| Address |
Main OT Complex First floor Department of Anaesthesia MDM Hospital Dr S N medical collage Jodhpur RAJASTHAN 342001
Jodhpur
RAJASTHAN
India
123 Vaishali avenue, Jhanwar road jodhpur
Jodhpur
RAJASTHAN
342008
India |
| Phone |
9414803554 |
| Fax |
|
| Email |
geetamanoj007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MDM Hospital Dr S N Medical collage Jodhpur RAJASTHAN 342001
India |
|
|
Primary Sponsor
|
| Name |
MDM Hospital Dr S N Medical Collage Jodhpur RAJASTHAN |
| Address |
Main operation theater
First floor MDM Hospital
Dr S N Medical College
Shastri Nagar Jodhpur Rajasthan 342001 |
| 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 |
| Dr Geeta Singariya |
MDM hospital Dr S N Medical collage Jodhpur |
Main OT Complex First floor Department of anesthesia M D M Hospital Dr S N Medical College Shastri Nagar Jodhpur Jodhpur RAJASTHAN
342001
RAJASTHAN
Jodhpur
RAJASTHAN |
9414803554
geetamanojkamal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr S N Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group M Modified Altemir |
Submental intubation with Modified Altemirs technique
Duration 5 - 20 minutes |
| Comparator Agent |
Group S Seldinger |
Submental intubation with Seldingers technique
Duration 5 - 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Panfacial trauma including
1. Le Fort I, II, III
2. Naso-orbital ethmoidal
3. Mandibular fractures
|
|
| ExclusionCriteria |
| Details |
1. Infection at the procedure site
2. Patient with associated co-morbidities, head
injury, coagulopathy or psychiatric illness
3. Patients requiring postoperative ventilatory
support
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to complete the procedure of submental intubation using Modified Altemirs technique and Seldingers technique in patients undergoing complex maxillofacial fracture fixation surgery |
up to 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Apnea time |
1 TO 2 Minutes |
| Intraoperative and postoperative complications between two groups |
Up to one month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/07/2024 |
| 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="6"
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-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geetamanojkamal@gmail.com].
- For how long will this data be available start date provided 31-03-2026 and end date provided 31-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will be conducted at Mathura Das Mathur Hospital, Dr S N Medical College Jodhpur after seeking clearance from the institutional ethical committee and obtaining written informed consent from the patients. This study will be done on the patients admitted to MDM hospital who will undergo complex maxillofacial fracture fixation surgery. To ensure inclusion in the study, each patient will be subjected to a detailed pre-anaesthetic evaluation based on detailed history from patient/attenders and thorough physical examination as well as preanaesthetic airway assessment (mouth opening, thyromental distance, Mallampati grade, dentition etc) will be done. Basic demographic data like name, age, sex, height, and body weight for will be recorded. Complete general physical examination, BMI check, investigations and ASA grading will be done. In all the patients, baseline investigations will be done to rule out any abnormalities. Coagulation profile, random blood sugar levels, tests for HIV, hepatitis B surface antigen and hepatitis C virus antigen infections, ECG and chest X-ray posterior-anterior view and associated co-morbidities will be done. The purpose and detailed procedure will be explained to the patients. Written informed consent will be taken from all the patients about the procedure. All patients will be kept nil by mouth as per standard guidelines before the scheduled time of surgery. Method- Before attempting oral endotracheal intubation, the connector will be released from the tube with the aid of mosquito forceps in such a way that it can be easily removed and reattached in the following steps. After obtaining proper consent initially all the patients will undergo orotracheal intubation by standard direct laryngoscopy using a reinforced endotracheal tube, Sterile painting and draping of the face and the neck will be done. Submental intubation will be done by either modified Altemir’s or seldinger’s technique.
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