| CTRI Number |
CTRI/2020/07/026731 [Registered on: 22/07/2020] Trial Registered Prospectively |
| Last Modified On: |
19/07/2020 |
| 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 types of Laryngoscopes undergoing surgery under General Anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Videolaryngoscope with Direct Laryngoscope using straight blade for Endotracheal Intubation in infants undergoing surgery under 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 |
Samriti Manhas |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Critical Care, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110023
India |
| Phone |
9268586607 |
| Fax |
|
| Email |
samdoc31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Critical Care, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110023
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Agrawal |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Critical Care, VMMC and Safdarjung Hospital, New Delhi
New Delhi
DELHI
110023
India |
| Phone |
9811030408 |
| Fax |
|
| Email |
nidhi.agrawal1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safdarjung hospital and Vardhman Mahavir Medical College. New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Safdarjung hospital and Vardhman Mahavir Medical College New Delhi India |
| Address |
Department of Anaesthesia and Intensive Care Ground floor, Main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College. New Delhi-110029, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Samriti |
Safdarjung hospital and Vardhman Mahavir Medical College |
Department of Anaesthesia and Intensive Care. Ground floor, main operation theatre building. Safdarjung hospital and Vardhman Mahavir Medical College. New Delhi- 110029 , India
New Delhi
DELHI |
9268586607
samdoc31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS 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: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Direct Laryngoscope with straight blade - Miller blade |
Patients will undergo endotracheal intubation using Direct laryngoscope with miller blade size 1 under general anaesthesia using appropriate sized PVC uncuffed endotracheal tube.In case of suboptimal visualization of vocal cords in first attempt, external laryngeal manipulation would be applied and if required head extension will follow and any improvement in view after optimizing manoeuvres will be noted. Failed attempt will be defined as any time the laryngoscope had to be withdrawn from the mouth either due to oxygen desaturation (peripheral O2 saturation 95%), or if the tracheal tube could not be passed successfully into the trachea (e.g. oesophageal intubation).If more than one attempt to intubate was required, the patient will be mask ventilated with 100% oxygen and sevoflurane in between the attempts. Timing will be observed by a member of the research team using a stop watch who will be blind to group allocation. Any change in blade size or use of bougie will be noted. |
| Intervention |
Videolaryngoscope with straight blade- Cmac miller |
Patients will undergo endotracheal intubation using Cmac videolaryngoscope with miller blade size 1 under general anaesthesia using appropriate sized PVC uncuffed endotracheal tube.In case of suboptimal visualization of vocal cords in first attempt, external laryngeal manipulation would be applied and if required head extension will follow
and any improvement in view after optimizing manoeuvres will be noted. Failed attempt will be defined as any time the laryngoscope had to be withdrawn from the mouth either due to oxygen desaturation (peripheral O2 saturation 95%), or if the tracheal tube could not be passed successfully into the trachea (e.g. oesophageal intubation).If more than one attempt to intubate was required, the patient will be mask ventilated with 100% oxygen and sevoflurane in between the attempts. Timing will be observed by a member of the research team using a stop watch who will be blind to group allocation. Any change in blade size or use of bougie will be noted. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
All children from 1 month to 1 year of age, weighing 3 to 10 kgs, of either sex, belonging to
American Society of Anaesthesiologists (ASA) grade I and II, undergoing elective surgical
procedures under general anaesthesia . |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway, upper respiratory tract infection, raised intracranial pressure
2. Congenital anomalies of head, face and neck, cardiovascular and respiratory system |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total time taken for successful endotracheal intubation |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time for achieving best glottic view and Tube insertion time
2. POGO (Percentage of glottic opening) score
3. Number of attempts for intubation
4. Intubation Difficulty Scale Score (IDS) |
1.Time for achieving best glottic view - at baseline
Tube insertion time - at baseline
2. POGO score - at baseline
3. Number of attempts for intubation- at baseline
4.IDS score - at baseline |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/07/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective of this study is to compare the efficacy of CMAC Miller videolaryngoscope with that of Miller direct laryngoscope in terms of total time taken for successful endotracheal intubation in infants undergoing elective surgical procedures under General Anaeshesia. |