| CTRI Number |
CTRI/2021/02/031546 [Registered on: 25/02/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing (King vision and CMAC-D videolaryngoscopes) two different techniques used to pass tube through airway passage in head and neck surgeries |
|
Scientific Title of Study
|
Comparison of intubation performance in King vision and CMAC-D videolaryngoscopes in head and neck surgeries |
| Trial Acronym |
KVCMACD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anchu Abraham |
| Designation |
post graduate student |
| Affiliation |
St. Johns Medical college Hospital, Bangalore |
| Address |
2nd floor Operation theatre complex, Department of Anesthesia and Critical Care, St. Johns Medical college Hospital, Bangalore
2nd floor Operation theatre complex, Department of Anesthesia and Critical Care, St. Johns Medical college Hospital, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9400453016 |
| Fax |
|
| Email |
anchu.abraham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MManjuladevi |
| Designation |
Associate Professor |
| Affiliation |
St. Johns Medical college Hospital, Bangalore |
| Address |
2nd floor Operation theatre complex,Department of Anesthesia and Critical Care, St. Johns Medical college Hospital, Bangalore
2nd floor Operation theatre complex, Department of Anesthesia and Critical Care, St. Johns Medical college Hospital, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9449059395 |
| Fax |
|
| Email |
drmanjula95@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anchu Abraham |
| Designation |
Post graduate student |
| Affiliation |
St. Johns Medical college Hospital |
| Address |
2nd floor Operation theatre complex,Department of Anesthesia and Critical Care, St. Johns Medical college Hospital, Bangalore
2nd floor Operation theatre complex,Department of Anesthesia and Critical Care, St. Johns Medical college Hospital, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
9400453016 |
| Fax |
|
| Email |
anchu.abraham@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Hospital
Sarjapura Road
Kormangala
Bangalore-560034 |
|
|
Primary Sponsor
|
| Name |
DrAnchu Abraham |
| Address |
St Johns Medical College Hospital Sarjapura Road Kormangala Bangalore-560034 |
| Type of Sponsor |
Other [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 Anchu Abraham |
St. Johns Medical college Hospital, Bangalore |
Room 3, 2nd floor , operation theatre complex St. Johns Medical college Hospital, Bangalore
Bangalore
KARNATAKA |
9400453016
anchu.abraham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, SJMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: X||New Technology, (3) ICD-10 Condition: 8||Other Procedures, (4) ICD-10 Condition: 5||Extracorporeal or Systemic Assistance and Performance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CMAC D videolaryngoscope |
Time taken for intubation, easiness for intubation, hemodynamic response like heart rate, Blood pressure, saturation and end tidal carbon dioxide to intubation and complications associated with the intubation |
| Comparator Agent |
Kingvision videolaryngoscope |
Time taken for intubation, easiness for intubation, hemodynamic response like heart rate, Blood pressure, saturation and end tidal carbon dioxide to intubation and complications associated with the intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex and belonging to ASA I and II category, patients undergoing surgeries in head and neck area (neurosurgical, otorhinolaryngoscopic
surgeries, surgical oncology) under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Surgeries requiring nasal intubation, patients with difficult mouth opening ( less than two finger breaths/ inter incisor distance less than 3 cm) , patients with maxillofacial injuries and pregnant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for intubation between two videolaryngoscopes |
preinduction,post induction, preintubation, post intubation(immediate,2min,4min,6min,8min,10min) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ease of intubation using Intubation difficulty scoring (IDS) |
immediate after intubation |
Intubation response such as baseline saturation
(SpO2), end-tidal carbon dioxide (EtCO2) concentration and hemodynamic responses-
Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean
Arterial Pressure (MAP) |
preinduction,post induction, preintubation, post intubation(immediate,2min,4min,6min,8min,10min) |
Complications such as dental damage, laceration of tongue / buccal mucosa, blood in
pharynx/ video laryngoscope blade, desaturation, bronchospasm will be recorded. |
immediate after intubation |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/03/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management is an integral part of general anaesthesia. In spite of recent developments in management of airway, complications arising from failed or difficult intubation are the leading cause of mortality and morbidity during anaesthesia. The unique design features and technique of use with KVVLs and CMAC-D blade may differ in intubation, oropharyngeal stimulation and consequent pressor response. We planned to conduct this study, since there is paucity of clinical research comparing these two video laryngoscopes (VLs) in head and neck patients. Our aim is to compare the intubation performance between the two VLs. Primary objective is to compare time of intubation and secondary objectives includes (a) ease of intubation (b) intubation response and (c) complications between the two VLs. |