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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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
 
 
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    
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%.

 
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