| CTRI Number |
CTRI/2021/08/035986 [Registered on: 26/08/2021] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| 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
|
To find out whether an anesthesia trainee doctor will be able to place the artificial tube in patient’s airway tube in first attempt by using either regular laryngoscope or by video based laryngoscope. |
|
Scientific Title of Study
|
Comparison of first intubation success rate of C-MAC video laryngoscope and direct laryngoscope guided intubation by anesthesiology residents following rapid sequence induction : Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Penumaka Lava KUmar |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of anaesthesiology and critical care,Old Hospital Building, Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9750187685 |
| Fax |
|
| Email |
lavakumarpenumaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthirajan P |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of anaesthesiology and critical care, Old Hospital Building, Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
sakthiab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakthirajan P |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Department of anaesthesiology and critical care, Old Hospital Building, Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
sakthiab8@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, DHANVANTRI NAGAR, PUDUCHERRY |
|
|
Primary Sponsor
|
| Name |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar, Puducherry, 605006, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Penumaka Lava Kumar |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Anaesthesiolohy Office, 2nd floor, Hospital block, Department of Anaesthesiology and Critical care, Jawaharlal institute of postgraduate medical education and research, Dhanvantri nagar, Puducherry
Pondicherry
PONDICHERRY |
9750187685
lavakumarpenumaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal institute of postgraduate medical education and research 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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endotracheal intubation with C-MAC video larygoscope |
Assessment of first intubation success rate with C-MaC video laryngoscope. Duration of therapy is from the time of induction of anaesthesia to successful tracheal intubation. |
| Comparator Agent |
Endotracheal intubation with Macintosh direct laryngoscope |
Assessment of first intubation success rate with Macintosh Direct laryngoscope. Duration of therapy is from the time of induction of anaesthesia to successful tracheal intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients 18-60 years of age requiring Rapid Sequence Induction for General Anaesthesia
2. American society of anaesthesiologists physical status classification of 1-3 |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway
2. Cervical spine injury
3. Patient on preoperative oxygen therapy
4. Pregnant woman
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the first intubation success rates of video laryngoscope and direct laryngoscope |
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of first attempt of intubation between the two study groups |
At the time of intubation |
| Any need for external laryngeal manipulation to improve the laryngeal view between the two groups. |
During intubation |
| Any need to use intubation aids other than stylet between the two groups |
During intubation |
| Any need for adjustments of cricoid pressure between the two groups |
During intubation |
| Incidence of hypoxia (less than 92%) between the two groups. |
During intubation |
| Laryngoscopic view between the two groups. |
During intubation |
| Incidence of regurgitation or aspiration |
During intubation |
| Heart rate and blood pressure changes during and after intubation |
Time from the start of intubation, every one minute till 10 minutes after intubation |
| Any mucosal or dental injury |
During intubation |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
Final Enrollment numbers achieved (Total)= "172"
Final Enrollment numbers achieved (India)="172" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
01/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
CMAC video laryngoscope has the design and technique of use similar to Macintosh direct laryngoscope and training required is also similar. By increasing the first intubation success rate it may reduce the complications associated with repeated and failed intubation. Currently the evidences to show the superiority of video laryngoscope over direct laryngoscope at operation rooms by anesthesiology trainee are limited CMAC video laryngoscope has the design and technique of use similar to Macintosh direct laryngoscope and training required is also similar. By increasing the first intubation success rate it may reduce the complications associated with repeated and failed intubation. Currently the evidences to show the superiority of video laryngoscope over direct laryngoscope at operation rooms by anesthesiology trainee are limited In this project after taking informed consent and getting examined by the anaesthesiologist , pateints will be randomly divided into two groups , group one will be intubated with Macintosh direct laryngoscope and group two with C-MAC video based laryngoscope. two groups will be divided by serially numbered sealed, opaque envelopes. An anaesthesia trainee doctor will perform laryngoscopy (a procedure to see your voice box by inserting a laryngoscope) and subsequently insert an artificial tube through the voice box and into the airway tube. Once the position of the artificial tube is checked, artificial ventilation will be commenced by connecting the tube to the ventilator. |