FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077386 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 25/11/2024
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 the Laryngeal Exposure rate in three different position using Channeled Video Laryngoscope in Operative room 
Scientific Title of Study   Comparison of the Laryngeal Exposure rate in Supine vs 25 degree vs 45 degree BackUp position using Channeled Video Laryngoscope in Operative room-A Randomized Observational Study 
Trial Acronym  nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tirtha Jivani 
Designation  Resident Doctor (MD Anaesthesiology) 
Affiliation  GMERS Medical College, Gotri, Vadodara 
Address  6th floor, Department of Anaesthesiology,GMERS Medical College, Gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  7016760170  
Fax    
Email  tirtha.jivani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anup Chandnani 
Designation  Professor and Head of Department  
Affiliation  GMERS Medical College, Gotri, Vadodara 
Address  2,jyoti park society, Behind Navrachna sports complex, New sama road, sama, Vadodara

Vadodara
GUJARAT
390024
India 
Phone  9925436505  
Fax    
Email  anupchandnani29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anup Chandnani 
Designation  Professor and Head of Department  
Affiliation  GMERS Medical College, Gotri, Vadodara 
Address  6th floor, department of anaesthesiology, GMERS medical college, gotri, Vadodara

Vadodara
GUJARAT
390021
India 
Phone  9925436505  
Fax    
Email  anupchandnani29@gmail.com  
 
Source of Monetary or Material Support  
GMERS hospital, Gotri Address: old TB campus, gotri main road, gotri, Vadodara-390021 Gujarat India 
 
Primary Sponsor  
Name  GMERS Hospital  
Address  Old TB Hospital campus, Gotri main road, Gotri, Vadodara-390021, Gujarat, India  
Type of Sponsor  Government medical college 
 
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 Tirtha Jivani  GMERS hospital  Anaesthesia department, 6th floor, Old TB hospital campus, gotri main road, gotri, vadodara-390021
Vadodara
GUJARAT 
7016760170

tirtha.jivani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IHEC GMERS medical college and hospital, Gotri  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 
Intervention  25 degree back up position  After thorough pre-anaesthetic evaluation will be done, including airway assessment and necessary laboratory investigations. All patients will be kept nil per oral according to fasting guidelines before the procedure. After receiving the patient in the operative room, a large bore IV cannula will be secured and infusion of IV Ringer lactate will be started. Patients will be placed in assigned position by using a preformed measuring tool. ASA standard monitors, including electrocardiogram, NIBP, pulse oximetry, and capnography will be attached. After pre-oxygenated with 100% oxygen for 3 minutes, patients will be induced under general anesthesia as per institutional protocol. After checking for adequate mask ventilation, injection succinylcholine 1.5 mg/kg body weight will be used to facilitate muscle relaxation. When adequate neuromuscular block is achieved, laryngoscopy will be done in 25 degree back up position not exceeding more than 2 min , using KINGS VISION channeled blade, following which image of glottis was captured. An anesthesiologist blinded to the position will assess the Cormack lehane grade and the percentage of glottic opening (POGO) score at 3-5 minutes using captured images. Intubation time will be noted from insertion of laryngoscope upto the appearance of capnograph on monitor and it will not exceeded more than 3 mins. study will be conducted for duration of 6 months 
Intervention  45 degree back up position  A thorough pre-anaesthetic evaluation will be done, including airway assessment and necessary laboratory investigations. All patients will be kept nil per oral according to fasting guidelines before the procedure. After receiving the patient in the operative room, a large bore IV cannula will be secured and infusion of IV Ringer lactate will be started. Patients will be placed in assigned position by using a preformed measuring tool. ASA standard monitors, including electrocardiogram, NIBP, pulse oximetry, and capnography will be attached. After pre-oxygenated with 100% oxygen for 3 minutes, patients will be induced under general anesthesia as per institutional protocol. After checking for adequate mask ventilation, injection succinylcholine 1.5 mg/kg body weight will be used to facilitate muscle relaxation. When adequate neuromuscular block is achieved, laryngoscopy will be done in 45 degree backup position not exceeding more than 2 min, using KINGS VISION channeled blade, following which image of glottis was captured. An anesthesiologist blinded to the position will assess the Cormack lehane grade and the percentage of glottic opening (POGO) score at 3-5 mins using captured images. Intubation time will be noted from insertion of laryngoscope upto the appearance of capnograph on monitor and it will not exceeded more than 3 min. study will be conducted for duration of 6 months 
Comparator Agent  Supine position  A thorough pre-anaesthetic evaluation will be done, including airway assessment and necessary laboratory investigations. All patients will be kept nil per oral according to fasting guidelines before the procedure. After receiving the patient in the operative room, a large bore IV cannula will be secured and infusion of IV Ringer lactate will be started. Patients will be placed in assigned position by using a preformed measuring tool. ASA standard monitors, including electrocardiogram, NIBP, pulse oximetry, and capnography will be attached. After pre-oxygenated with 100% oxygen for 3 minutes, patients will be induced under general anesthesia as per institutional protocol. After checking for adequate mask ventilation, injection succinylcholine 1.5 mg/kg body weight will be used to facilitate muscle relaxation. When adequate neuromuscular block is achieved, laryngoscopy will be done in supine position not exceeding more than 2 min, using KINGS VISION channeled blade, following which image of glottis was captured. An anesthesiologist blinded to the position will assess the Cormack lehane grade and the percentage of glottic opening (POGO) score at 3-5 mins using captured images. Intubation time will be noted from insertion of laryngoscope upto the appearance of capnograph on monitor and it will not exceeded more than 3 min. study will be conducted for duration of 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All elective surgeries posted under general Anaesthesia.
ASA I and II patients
Mouth Opening more than 3 fingers
Mallampati Grade 1,2 and 3 
 
ExclusionCriteria 
Details  Patient Refusal
Mouth Opening less than 3 fingers
Any Feature of anticipated difficult intubation
BMI more than 30 kg per meter square
Cervical Spine Injury
Pregnant female
History of previous oral cavity Surgery  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare laryngeal exposure rate in Supine vs 25 Degree vs 45 Degree back up position  laryngeal exposure rate in Supine vs 25 Degree vs 45 Degree back up position by using POGO SCORE and CORMACK LEHANE GRADE between 3 - 30 minutes after intubation  
 
Secondary Outcome  
Outcome  TimePoints 
To assess Intubation time
To assess first pass attempt rate
Use of accessory Intubation aids
To assess the comfort of anaesthesiologist in all three position
 
Intubation time will be assessed immediately at time of inubation (from laryngoscopy to appearance of square waveforms in capnography
Anaesthesiologist comfort by Likert satisfaction scale immediately after intubation within 30 minutes  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   Phase 3 
Date of First Enrollment (India)   06/12/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM and OBJECTIVE:

We aim to compare the Laryngeal exposure rate in Supine vs. 25 Degree vs. 45 Degree back up position using channeled video laryngoscope. 

Primary Objective :

To compare laryngeal exposure rate in Supine vs. 25 Degree vs. 45 Degree back up position, by POGO score and Cormack lehane grading.

Secondary objective:

  1. To assess Intubation time
  2. To assess first pass attempt rate
  3. Use of accessory Intubation aids.
  4. To assess the comfort of anaesthesiologist in all three position.

STUDY PROTOCOL:

Ethical consideration: This study will be conducted after obtaining approval ethical committee of GMERS medical college and Hospital, Gotri, Vadodara and topic being registered under CTRI (Clinical trial registry of India.)

Study design: Prospective Randomized , Single Blinded, Observational study

Study setting: Tertiary care teaching hospital (GMERS Medical College and Hospital, Gotri, Vadodara)

Study duration: over 6 months after approval from ethical committee

Study population:  All ASA I and II patients undergoing elective surgery under general anesthesia at GMERS college and hospital, gotri.

Inclusion criteria:

  1. Patient aged between 18 to 60 years
  2. Either gender
  3. All elective surgeries of ASA I and II patients
  4. MO more than 3F

5.     MP grade 1,2 and 3

Exclusion criteria:

1.     Patient’s refusal

2.     Any features of Anticipated difficult intubation

3.     Mouth opening less than 3F

4.     BMI more than 30 kg/m2

5.     Previous oral cavity surgery

6.     Pregnant females

7.     Cervical spine injury

 

 

METHOD:

Patients will be screened in pre-anesthetic check-up and those fulfilling the eligibility criteria will be informed verbally as well as in written about the study.  After obtaining written and informed consent, willing patients will be enrolled in the study.

Randomization and allocation:

Patients will be randomly divided into three groups by simple randomization. Randomization and allocation will be conducted by a person not involved in the study. The groups are as follows:

Group S: Patients will be intubated in supine position 

Group 25d degree: Patients will be intubated in 25 degree back up

Group 45 degree: Patients will be intubated in 45degree back up

 

Study Procedures:

•        A thorough pre-anaesthetic evaluation will be done, including airway assessment and necessary laboratory investigations.

•        All patients will be kept nil per oral according to fasting guidelines before the procedure.

•        After receiving the patient in the operative room, a large bore IV cannula will be secured and infusion of IV Ringer lactate will be started.

•         Patients will be placed in assigned position by using a preformed measuring tool.

•        ASA standard monitors, including electrocardiogram, NIBP, pulse oximetry, and capnography will be attached.

•        After pre-oxygenated with 100% oxygen for 3 minutes, patients will be induced under general anesthesia as per institutional protocol.

•        After checking for adequate mask ventilation, injection succinylcholine 1.5 mg/kg body weight will be used to facilitate muscle relaxation.

•         When adequate neuromuscular block is achieved, laryngoscopy will be done in all three groups, using KINGS VISION channeled blade, following which image of glottis was captured.

•        An anesthesiologist blinded to the position will assess the Cormack lehane grade and the percentage of glottic opening (POGO) score using captured images.

•        Intubation time will be noted from insertion of laryngoscope upto the appearance of capnograph on monitor. 

 

DATA COLLECTION:

The following parameters will be observed and data collected in a tabular form.

  1. Number of attempts of intubation
  2. Intubation time (from laryngoscopy to appearance of square waveforms in capnography)
  3. Anaesthesiologist comfort by Likert satisfaction scale (1–Very dissatisfied,2–Dissatisfied,3–Unsure,4–Satisfied,5–Very satisfied)
  4. Use of accessory intubation aids
  5. Hemodynamic parameters to be noted at 1,3,5 and 15 min after intubation.

 

SAMPLE SIZE AND SAMPLING METHOD:

 

We will be including all the patients posted under general anesthesia for elective surgery full filling study criteria for 6 months and divided equally in three groups in ratio 1:1:1

The results of the observation obtained in each group were tabulated, compiled, and statistically analyzed using ANOVA test and chi-square test.

 
Close