CTRI Number |
CTRI/2021/04/033279 [Registered on: 30/04/2021] Trial Registered Prospectively |
Last Modified On: |
25/09/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
COMPARISON BETWEEN C MAC VIDEO LARYNGOSCOPE AND TUOREN VIDEO LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN PEDIATRIC POPULATION UNDERGOING GENERAL ANAESTHESIA |
Scientific Title of Study
|
C MAC VIDEO LARYNGOSCOPE VERSUS TUOREN VIDEO LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN THE PAEDIATRIC POPULATION 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 |
DR ASHIKA JOHNEY |
Designation |
Post Graduate student, M. D. Anaesthesiology |
Affiliation |
Maulana Azad Medical College and Associated Hospitals |
Address |
Department of Anaesthesiology and Intensive Care, C/O Dr Sonia Wadhawan, 3rd floor, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002
Central DELHI 110002 India |
Phone |
9310138509 |
Fax |
|
Email |
ashika.johney@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR SONIA WADHAWAN |
Designation |
Director Professor |
Affiliation |
Maulana Azad Medical College and Associated Hospitals |
Address |
Department of Anaesthesiology and Intensive Care, 3rd floor, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002
Central DELHI 110002 India |
Phone |
9968604218 |
Fax |
|
Email |
soniawadhawan@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
DR ASHIKA JOHNEY |
Designation |
Post Graduate student, M. D. Anaesthesiology |
Affiliation |
Maulana Azad Medical College and Associated Hospitals |
Address |
Department of Anaesthesiology and Intensive Care, C/O Dr Sonia Wadhawan, 3rd floor, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002
Central DELHI 110002 India |
Phone |
9310138509 |
Fax |
|
Email |
ashika.johney@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002 |
|
Primary Sponsor
|
Name |
Maulana Azad Medical College |
Address |
Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002 |
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 Ashika Johney |
Lok Nayak Hospital |
OT Block, Department of Anaesthesiology and Intensive Care, Delhi Gate, Jawahar Lal Nehru Marg, New Delhi 110002 Central DELHI |
9310138509
ashika.johney@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals |
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 |
Intervention |
Laryngoscopy and Endotracheal Intubation with C Mac video laryngoscope in paediatric population undergoing general anaesthesia |
Children in this group will undergo laryngoscopy and endotracheal intubation by using C Mac video laryngoscope with appropriate C Mac blade of Macintosh size 2/3, for which Intubation Difficulty Scale Score, time taken to intubate, hemodynamic response and post operative complications will be noted |
Comparator Agent |
Laryngoscopy and Endotracheal Intubation with Tuoren video laryngoscope in paediatric population undergoing general anaesthesia |
Children in this group will undergo laryngoscopy and endotracheal intubation by using Tuoren video laryngoscope with appropriate blade of Macintosh size 2, for which Intubation Difficulty Scale Score, time taken to intubate, hemodynamic response and post operative complications will be noted |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
8.00 Year(s) |
Gender |
Both |
Details |
Patients belonging to American Society of Anaesthesiologists (ASA) Physical Grade I and II undergoing elective surgery under general anaesthesia requiring endotracheal intubation. |
|
ExclusionCriteria |
Details |
1. Patients with mouth opening less than or equal to 2.5 cm
2. Patients belonging to Modified Mallampati class III and IV
3. Patients with predicted difficult airway (anatomical deformity of head and neck, fracture of maxillofacial region or tumors of oral cavity). |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Intubation Difficulty Scale (IDS) score, consisting of seven parameters |
During laryngoscopy and endotracheal intubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time taken to intubate |
Between blade entry past the lips and the appearance of first square wave capnograph |
Intraoperative hemodynamic response measured by:
1.Heart rate trend in the intraoperative period
2. Mean arterial pressure trend during the intraoperative period |
Baseline - before induction of anaesthesia
At the time of insertion of airway device
Every 2 minutes after insertion of device for first 10 minutes |
Complications including:
1. Blood staining on the device or tracheal tube
2. Post operative sore throat |
Recovery period after surgery
24 hours postoperatively |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
05/05/2021 |
Date of Study Completion (India) |
30/06/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
30/06/2022 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashika.johney@gmail.com].
- For how long will this data be available start date provided 31-03-2023 and end date provided 31-03-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
|
The pediatric airway management poses a challenge to anaesthesiologists across the globe due to the major anatomical, physiological and developmental differences in them as compared to the adult population. One of the prime causes of anaesthetic morbidity and mortality is complications arising from difficult tracheal intubation despite recent evolution in airway management strategies. Direct laryngoscopy (DL) has been regarded as the gold standard for endotracheal intubation (ETI) in both paediatric and adult patients. Direct laryngoscopy guided tracheal intubation requires the three axes (oral, pharyngeal and laryngeal) to be arranged in one straight line, achieved by placing the head and neck in the sniffing position. Up to 4.7% of paediatric patients undergoing general anaesthesia (GA) may present with difficult intubation. Hence, one has to be equipped to manage a situation of difficult airway at all times.
In an attempt to reduce the morbidity and mortality associated with difficult airway, several video laryngoscopes (VLs) such as Glidescope, Truview, Airtraq and C-MAC have been introduced into clinical practice. These video laryngoscopes ensure a better glottic view, with greater intubation success and reduced complications as compared to the conventional direct laryngoscopy in the adult population, and are being increasingly used in the paediatric population. Flexible fiberoptic bronchoscopes are used in difficult pediatric airway, but are technically more challenging than the video laryngoscopes.
The C-MAC VL is a fourth generation VL, with a standard Miller/Macintosh blade with a distal camera at two-thirds of its length. It has been successfully used for visualization of the larynx in various difficult airway cases. It is available in the Macintosh blade sizes (sizes 2, 3, and 4) and pediatric Miller sizes (sizes 0 and 1). It also has a D- blade for difficult airways. Tuoren is a newer video laryngoscope, which has advantages of disposable blades, large screen size, anti-fogging feature and a longer battery life, in addition to being portable and cost effective. It has a blade that has retained the shape and curvature of Macintosh blade. The reusable laryngoscope handle is fully compatible with 6 size of blades: Mac2/Mac3/Mac4/MIL00/MIL0/MIL1. Hence, in this randomized comparative study, we aim to compare C Mac and Tuoren video laryngoscope guided endotracheal intubation using micro-cuffed endotracheal tube in paediatric patients undergoing elective surgery under general anaesthesia. |