| CTRI Number |
CTRI/2021/09/036788 [Registered on: 23/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of Ambu Airway and Intubating Laryngeal Mask Airway for tracheal intubation in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparative Evaluation of Ambu Airway and Intubating Laryngeal Mask Airway for tracheal intubation in patients undergoing general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumedha Biswas |
| Designation |
Junior Resident |
| Affiliation |
Dr. D.Y.Patil Medical College and Research Institute |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Department of Anaesthesiology
Sant Tukaram Nagar Pimpri Pune
Dr D Y Patil Medical College Hospital and Research Centre
Department of Anaesthesiology
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9094042623 |
| Fax |
|
| Email |
biswasumedha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VRR Chari |
| Designation |
Professor |
| Affiliation |
Dr. D.Y.Patil Medical College and Research Institute |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Department of anaesthesiology
Sant Tukaram Nagar Pimpri Pune
Dr D Y Patil Medical College Hospital and Research Centre
Department of Anaesthesiology
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9665932588 |
| Fax |
|
| Email |
drvrrchari2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumedha Biswas |
| Designation |
Junior Resident |
| Affiliation |
Dr. D.Y.Patil Medical College and Research Institute |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Department of Anesthesiology
Sant Tukaram Nagar Pimpri Pune
Dr D Y Patil Medical College Hospital and Research Centre
Department of Anesthesiology
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9094042623 |
| Fax |
|
| Email |
biswasumedha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Medical College Hospital And Research Centre |
| Address |
Dr D Y Patil Medical College Hospital and Research Centre
Sant Tukaram Nagar Pimpri Pune |
| 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 |
| Dr Sumedha Biswas |
Dr D Y Patil Medical College Hospital and Research Centre |
Operation Theatre 5th floor
Dr D Y Patil Medical College Hospital and Research Centre
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
9094042623
biswasumedha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics sub committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubation using intubating laryngeal mask airway |
Patients were intubated using AMBU Aura - i intubating laryngeal mask airway for the duration of surgery and extubated at the end of surgery |
| Intervention |
Intubation using intubating laryngeal mask airway |
Patients were intubated using FASTRACH intubating laryngeal mask airway for the duration of surgery and extubated at the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
60 adult surgical candidates aged 18 to 80 years with American Society of Anaesthesiologists physical status grading I-III with a Mallampati score of I or II presenting for elective surgery requiring general anaesthesia |
|
| ExclusionCriteria |
| Details |
Elective surgical candidates with previously known difficult airway, requiring prone positioning, interincisor distance <2.5cm, thyromental distance<5cm, or with clinically suspected difficult airway or with contraindications to laryngeal mask airway insertion or with indications for rapid sequence induction |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total intubation time beginning from the time of insertion of supraglottic airway upto successful endotracheal tube intubation verified by detection of carbon dioxide on the capnogram |
Total intubation time beginning from the time of insertion of supraglottic airway upto successful endotracheal tube intubation verified by detection of carbon dioxide on the capnogram. T1 - time of insertion of LMA. T2 - time of insertion of endotracheal tube. T3 - time of removal of LMA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time for LMA insertion, Time for endotracheal tube insertion, number of participants in whom supraglottic airway insertion was successful on first attempt, number of participants in whom endotracheal tube insertion was successfull on first attempt, number of participants with overall successful for supraglottc airway device placement, Ease of Supraglottic airway insertion, number of participants with overall intubation success, postoperative discomfort in post-anaesthesia care unit |
Total intubation time beginning from the time of insertion of supraglottic airway upto successful endotracheal tube intubation verified by detection of carbon dioxide on the capnogram
T1 -time of insertion of LMA
T2 -time of insertion of endotracheal tube
T3 - time of removal of LMA |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 elective surgical candidates aged 18-80 years belonging to ASA I-III grading physical status undergoing general anaesthesia will be divided into 2 groups of 30 each by a computer generated randomised allocation table. Group F will be intubated using FASTRACH intubating laryngeal mask airway and Group A will be intubated using AMBU Aura-i intubating laryngeal mask airway.The total intubation time will be recorded and compared between both groups along with ease of intubation and first attempt success rate of intubation between the two groups and incidence of postoperative sore throat will be recorded. Based on this a comparative evaluation between FASTRACH and Ambu Aura-i laryngeal mask airways will be done. |