| CTRI Number |
CTRI/2018/05/014068 [Registered on: 23/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/05/2018 |
| 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 video laryngoscopes in patients undergoing tracheal intubation with cervical spine immobilization |
|
Scientific Title of Study
|
Comparision of Two Video Laryngoscope: Guide Channel and Optical Laryngoscope in patients undergoing tracheal intubation with cervical spine immobilization |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alka Yadav |
| Designation |
DNB Trainee |
| Affiliation |
Artemis Hospitals, Gurgaon, Haryana, India |
| Address |
Department of Anaesthesiology,
Artemis Hospitals,
Sector 51,
Gurgaon
HARYANA
122001
India |
| Phone |
8607706935 |
| Fax |
|
| Email |
dralkayadava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Y Naveen |
| Designation |
Consultant |
| Affiliation |
Artemis Hospitals |
| Address |
Artemis Hospitals,
Sector 51,
Gurgaon
HARYANA
122001
India |
| Phone |
9891613461 |
| Fax |
|
| Email |
naveen2y@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Misra |
| Designation |
Chairperson, Department of Anaesthesiology |
| Affiliation |
Artemis Health Institute |
| Address |
Department of Anaesthesiology,
Artemis Hospitals,
Sector 51
Gurgaon
HARYANA
122001
India |
| Phone |
9811285958 |
| Fax |
|
| Email |
raje_del@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Artemis Health Institute |
| Address |
Sector 51,
Gurgaon,
Haryana- 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Alka Yadav |
Artemis Health Institute |
Department of Anaesthesia,
First Floor,
Artemis Hospitals,
Sector 51,
Gurgaon
Gurgaon
HARYANA |
8607706935
dralkayadava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I and ASA II
Age between 18-65 years
Mallampati Class I, II and III, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison between Kingvision videolaryngoscope and Truview laryngoscope |
Comparison of two video laryngoscope: guide channel and optical laryngoscope in patients undergoing tracheal intubation with cervical spine immobilization. |
| Comparator Agent |
Kingvision and Truview video laryngoscope |
Video laryngoscopes used for intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and ASA II
Mallampati class I, II and III |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway (Mallampati class IV, thyromental distance <6 cm,
interincisor gap <3.5 cm).
Presence of risk factor for gastric aspiration e.g. pregnancy.
Uncontrolled hypertension and diabetes mellitus, cardiac disease, hepatic and renal
impairment.
Loose teeth and artificial dentures.
BMI > 35.
Oral pathology.
CNS disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
IDS score was less in King Vision ® (1.63±1.25) as compared to Truview ®
EVO2 (2.03±1.38). But the difference between King Vision and Truview ®
EVO2 groups were not statistically significant. |
During laryngoscopy and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean duration of intubation was significantly longer in Truview® EVO2 group as compared to King Vision®.
Haemodynamic parameters (HR, MAP, Spo2) were comparable in both groups with no statistical significant difference.
No major complication in any of the groups. |
During laryngoscopy and intubation and 5 minutes post intubation. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2016 |
| Date of Study Completion (India) |
31/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Following parameters were observed: 1. Parameters of Intubation Difficulty Scale (IDS) 2. Time taken for intubation 3. Haemodynamic parameters 4. Complications, if any In patients with cervical spine immobilization, intubation with King Vision® videolaryngoscope required lesser time than using Truview®EVO2 laryngoscope. No significant difference was found in laryngoscopic view and IDS score with both the devices. There is no statistically significant difference in haemodynamic parameters while intubation and post-intubation in both groups. There is no major complication in any of the groups. To conclude both types of laryngoscopes are safe and efficient for intubation in patients with cervical spine immobilization considering high overall success rate and no significant trauma involved.
|