| CTRI Number |
CTRI/2025/08/093899 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of Two Airway Techniques for Patients with Anticipated Difficult Ventilation: Traditional Face Mask vs. Tracheal Tube in Pharynx (TTIP) |
|
Scientific Title of Study
|
Comparison of the effectiveness of traditional mask ventilation technique with Tracheal Tube in Pharynx in patients having Anticipated difficult Ventilation: A prospective randomised Open-Label Crossover 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 |
Dr Pallavi Kumari |
| Designation |
Post Graduate trainee Department of Anaesthesiology and Critical Care |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCE |
| Address |
Department of Anaesthesia, First floor, Ward block, Indira Gandhi Institute Of Medical Sciences, Patna, Sheikhpura,
Patna,
BIHAR
800014
India
Kadamkuan Patna
Patna
BIHAR
800014
India |
| Phone |
7091653072 |
| Fax |
|
| Email |
pkm.official1908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annu Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia, First floor, Ward block, Indira Gandhi Institute Of Medical Sciences, Patna, Sheikhpura,
Patna,
BIHAR
800014
India
Patna
BIHAR
800014
India |
| Phone |
07385161632 |
| Fax |
|
| Email |
anucdry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annu Choudhary |
| Designation |
Assistant Professor |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia, First floor, Ward block, IGIMS, Patna, Sheikhpura,
Patna,
BIHAR
800014
India
Patna
BIHAR
800014
India |
| Phone |
07385161632 |
| Fax |
|
| Email |
anucdry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences Sheikhpura,
Patna,
Bihar
800014
India |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia IGIMS |
| Address |
Department of Anaesthesia, First floor, Ward block, IGIMS, Patna, Sheikhpura,
Patna,
BIHAR
800014
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pallavi Kumari |
Indira Gandhi Institute of Medical Sciences |
Department of Anaesthesia, First floor, Ward block, IGIMS, Patna, Sheikhpura,
Patna,
BIHAR
800014
India
Patna
BIHAR |
7091653072
pkm.official1908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee |
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 |
Ventilation by Bag-mask (standard two-hand mask technique) |
Dose- not applicable, procedure based trial
Route-face mask applied over patient mouth and nose
Frequency -single application during induction of anaesthesia
Duration - ventilation for 90 seconds (roughly 18 breaths in Pressure Control Mode with same settings as interventional agent) |
| Intervention |
Ventilation by tracheal tube in pharynx |
Dose - Not applicable (procedure based intervention)
Route- oropharyngeal insertion of standard Tracheal Tube until tip reaches hypopharynx (tragus -incisor distance)
Frequency: single application after induction of anaesthesia
Duration - ventilation for 90 seconds (roughly 18 breaths in Pressure Control Mode with RR12 , I:E 1:2, PIP 20cm H2O no PEEP) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for elective surgery under general anaesthesia with endotracheal intubation and
Patients with anticipated difficult ventilation
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of expired tidal volume of ventilation with TTIP vs mask |
90 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of ventilation parameters (PAP in cmH2O, end-tidal CO2 (mm Hg), inspired tidal volume, TV I (ml), expired tidal volume TV e (ml) between the two Ventilation strategies in each subgroup of difficult mask ventilation.
|
90 seconds |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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)
|
15/09/2025 |
| 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 - NO
|
|
Brief Summary
|
This study is a prospective, randomized, open-label crossover trial comparing the effectiveness of traditional mask ventilation with the tracheal tube in pharynx (TTIP) technique in patients with anticipated difficult mask ventilation. The primary objective is to compare expired tidal volumes achieved by both methods, while secondary outcomes include other ventilation parameters, success rate, order of effectiveness, and adverse events. A total of 148 adult patients undergoing elective surgery under general anaesthesia will be enrolled, selected based on predictors like obesity, beard, edentulism, elderly age, and snoring. Following standard induction with fentanyl, propofol, and rocuronium, patients will be ventilated using both methods in a randomized sequence. TTIP involves blind insertion of an endotracheal tube into the pharynx to bypass common causes of upper airway obstruction. The study aims to determine whether TTIP can be a reliable alternative to mask ventilation in managing anticipated difficult airways.
|