| CTRI Number |
CTRI/2018/03/012835 [Registered on: 26/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/03/2018 |
| 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 nonchannelled videolaryngoscopes with standard direct laryngoscope for endotracheal intubation in adult patients undergoing elective surgery." |
|
Scientific Title of Study
|
"Comparison of two nonchannelled videolaryngoscopes with standard direct laryngoscope for endotracheal intubation in adult patients undergoing elective surgery." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Abhyankar |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. |
| Address |
Department Of Anaesthesiology and Intensive Care, ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
7838893005 |
| Fax |
|
| Email |
prachiabhyankar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikki Sabharwal |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesiology and Intensive Care, ground floor, main OT bulding, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029.
New Delhi
DELHI
110029
India |
| Phone |
9810774396 |
| Fax |
|
| Email |
nikkisabharwal162@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Abhyankar |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029. |
| Address |
Department of Anaesthesiology and Intensive Care, ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029.
New Delhi
DELHI
110029
India |
| Phone |
7838893005 |
| Fax |
|
| Email |
prachiabhyankar24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi-110029. |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi |
| Address |
Department of Anaesthesiology and Intensive Care, ground floor, main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi. |
| Type of Sponsor |
Government medical college |
|
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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 |
| Dr Prachi Abhyankar |
Vardhman Mahavir Medical College and Safdarjung Hospital. |
Department of Anaesthesiology and Intensive Care, ground floor, main OT building.
New Delhi
DELHI |
7838893005
prachiabhyankar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult patients (18-65)years of either gender with ASA grade I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIRECT MACINTOSH LARYNGOSCOPE |
Patients in this group will be given general anaesthesia( induction with inj Fentanyl 2mcg/kg iv, inj Propofol 2mg/kg iv and inj vecuronium 0.1kg/kg iv). After induction, patient will be intubated by using Direct Macintosh laryngoscope. Only 2 attempts will be given. In case of failure, subsequent airway management will be done according to the standard protocol of the hospital |
| Intervention |
Videolaryngoscope(VL) |
Patients in this group will be given general anaesthesia(induction with inj Fentanyl 2mcg/kg iv, inj Propofol 2mg/kg iv, and inj vecuronium 0.1kg/mg iv.) After induction, patient will be intubated by using videolaryngoscope. Only 2 attempts will be given. In case of failure, subsequent airway management will be done according to the standard protocol of the hospital. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II, having BMI ≤30kg/m2 and standard airway parameters within normal range, scheduled for elective surgery under general anaesthesia requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. Patients who have anticipated difficult airway and modified Mallampati class III or IV
2. Haemodynamic instability, hypertion, morbid obesity, cardiac, renal, hepatic, endocrine, pulmonary dysfunction, upper respiratory tract infection.
3. Cervical spine instability.
4. Pregnancy |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To comparatively evaluate the first attempt success rate for endotracheal intubation |
At the time of intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To comparatively eveluate the modified Cormac-Lehane view, time and ease of laryngoscopy and intubation |
At the time of intubation. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/12/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
1. Channa AB. Video laryngoscopes. Saudi J Anaesth. 2011;5:357-59.2. 2.Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012;109:68-85.7. 3. Hurford WE. The Video Revolution: A New View of Laryngoscopy. Respir Care. 2010;55:1036-45.20. 4. Cavus E, Thee C, Moeller T, Kieckhaefer J, Doerges V, Wagner K. A randomized, controlled crossover comparison of the C-MAC videolaryngoscope with direct laryngoscopy in 150 patients during routine induction of anaesthesia. BMC Anesthesiol. 2011;11:6.24. 5. Myatra SN, Shah A, Kundra P, Patwa A, Ramkumar V, Divatia JV et al. All India Airway Association 2016 guidelines for the management of unanticipated difficult tracheal intubation in adults. 2016;60:885-98. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
1. To comparatively evaluate the first attempt success rate for endotracheal intubation using direct Macintosh laryngoscope or Videolaryngoscope in patients undergoing elective surgery. 2. To comparatively evaluate the modified Cormac-Lehane view, time and ease of laryngoscopy and intubation.
|