| CTRI Number |
CTRI/2023/02/050036 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of laryngeal opening seen in bed-up-head-elevated position Macintosh laryngoscopy with conventional C-MAC video laryngoscopy |
|
Scientific Title of Study
|
Comparison of laryngeal exposure in bed-up-head-elevated position Macintosh laryngoscopy with conventional C-MAC video laryngoscopy: a randomized non-inferiority trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
prashant sirohiya |
| Designation |
Assistant Professor |
| Affiliation |
NCI,AIIMS |
| Address |
Room No.117, Academic Block, National Cancer Institute (AIIMS), Badsa, Jhajjar Jhajjar HARYANA 124105 India |
| Phone |
8824090277 |
| Fax |
|
| Email |
SIROHIYAPRASHANT@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
Prashant Sirohiya |
| Designation |
Assistant Professor |
| Affiliation |
NCI,AIIMS |
| Address |
Room No.117, Academic Block, National Cancer Institute (AIIMS) Badsa, Jhajjar Jhajjar HARYANA 124105 India |
| Phone |
8824090277 |
| Fax |
|
| Email |
SIROHIYAPRASHANT@GMAIL.COM |
|
Details of Contact Person Public Query
|
| Name |
prashant sirohiya |
| Designation |
Assistant Professor |
| Affiliation |
NCI,AIIMS |
| Address |
Room No.117, Academic Block, National Cancer Institute (AIIMS) Badsa, Jhajjar Jhajjar HARYANA 124105 India |
| Phone |
8824090277 |
| Fax |
|
| Email |
SIROHIYAPRASHANT@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| National Cancer Instiute (Jhajjar), AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Prashant Sirohiya |
| Address |
NCI,Badsa,Jhajjar |
| Type of Sponsor |
Other [] |
|
|
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 Prashant Sirohiya |
National Cancer Institute |
Department of Anesthesia, Room No. 111, 3rd Floor Hospital Block, Badsa, Jhajjar Jhajjar HARYANA |
8824090277
sirohiyaprashant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BUHE Macintosh laryngoscopy followed by C-MAC laryngoscopy |
First patients will be positioned in the BUHE position, by breaking the operating table at the hip joint, and elevating the head of the bed up to 20° to 30° and standard 4.5-cm ring beneath head, with end point being horizontal alignment between the patient’s external acoustic meatus and sternal angle. POGO and CL grade will be noted. Then Conventional C- MAC Laryngoscopy will be performed in supine position with no ring beneath head. Again POGO and CL grade will be noted and intubation will be done. |
| Intervention |
C-MAC Laryngoscopy followed by BUHE Macintosh Laryngoscopy |
First Conventional C- MAC Laryngoscopy will be performed in supine position with no ring beneath head. POGO and CL grade will be noted. Then Patients will be positioned in the BUHE position, by breaking the operating table at the hip joint, and elevating the head of the bed up to 20° to 30° and standard 4.5-cm ring beneath head, with end point being horizontal alignment between the patient’s external acoustic meatus and sternal angle. Again POGO and CL grade will be noted and intubation will be done. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- American Society of Anesthesiologists (ASA) physical status (PS) classification I to III
- Planned for elective surgeries requiring ETI under general anesthesia (GA)
- Age Group: 18 to 65 years of age
|
|
| ExclusionCriteria |
| Details |
- Patients with ischemic heart disease, cerebrovascular disease, respiratory disease, or body mass index (BMI) >35 kg·m−2.
- In addition, patients who require rapid sequence induction or having airway obstruction, small mouth opening, or contraindication to neck extension
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - To note down the change in laryngeal exposure (percentage of Glottic Opening {POGO} score |
At baseline, the time of Laryngoscopy and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare in both groups-
• Cormack Lehane Grading
• Time required for intubation (TRI)
• Number of intubation attempts
• Number of Operators
• Number of Alternative techniques (Stylet, Bougie-Guided intubation)
• Lifting force required (Normal/ Increased)
• Need for external laryngeal maneuver
• First pass intubation success
• Vocal cord mobility (Abducted/ Adducted)
• Effort during intubation (assessed based on Numeric rating scale, 0 being no effort, 10 being maximal effort), and
• Complications during intubation (esophageal intubation, hypoxia, and hypotension) will be recorded.
|
At baseline, the time of Laryngoscopy and intubation |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
16/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Many difficult tracheal intubations are unanticipated
and can have catastrophic consequences. The patient’s position before
intubation is of great importance in increasing the success rate of tracheal
intubation. The sniffing position is the most widely accepted position for
tracheal intubation. Lee et
al studied the effects of 25 degrees of bed elevation to the supine position
and found better laryngeal visualization. Other researchers also
showed the effectiveness of bed-up-head–elevated (BUHE) position in
endotracheal intubation (ETI) with increased success rates of tracheal
intubation, decreased airway complications, reduced need for airway adjuncts,
decreased time to endotracheal intubation, and prolonged safe apnea time for
intubation. Over the last many years, there has been increasing in
the use of video-assisted laryngoscopy (VAL) devices. Literature had showed
that VAL is associated with better laryngeal exposure and an increased success
rate of endotracheal intubation. 10,11 The higher cost associated
with VAL, especially in developing countries limits its use in patients
undergoing endotracheal intubations in a low-resource setting.
Currently, to our knowledge, no literature is
there that compared laryngoscopy in the BUHE position with conventional C-MAC
laryngoscopy. We wish to perform a noninferiority trial comparing between
Macintosh laryngoscopy in the BUHE position and laryngoscopy via conventional
C-MAC laryngoscopy in the supine position. Our primary objective is to determine
whether laryngeal exposure in the BUHE position Macintosh laryngoscopy is non-inferior
to conventional C-MAC laryngoscopy. We hypothesize that Macintosh laryngoscopy
in the BUHE position provides noninferior laryngeal exposure when compared to conventional
C-MAC laryngoscopy in the supine position, within the bounds of the predefined
margin of noninferiority set at −15%. |