FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/096869 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
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 Fingers Grip and Pen-Holding Grip Techniques for Orotracheal Intubation 
Scientific Title of Study   A RANDOMISED STUDY TO COMPARE THE-FINGERS GRIP TECHNIQUE VS. CONVENTIONAL PEN-HOLDING GRIP TECHNIQUE TO HOLD AN ENDOTRACHEAL TUBE FOR OROTRACHEAL INTUBATION AT SMS MEDICAL COLLEGE JAIPUR. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Kumar 
Designation  Junior Resident 
Affiliation  SMS Medical College Jaipur 
Address  Department of Anaesthesia, Second floor, OT Complex, Dhanwantri building. Sawai Man Singh Medical College and Attached Hospital Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9024057465  
Fax    
Email  drchhapola15@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr RAJNI MATHUR  
Designation  SENIOR PROFESSOR 
Affiliation  SMS MEDICAL COLLEGE JAIPUR 
Address  Department of Anaesthesia, Second floor, OT Complex, Dhanwantri building. Sawai Man Singh Medical College and Attached Hospital Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9829357194  
Fax    
Email  RAJNIMATHUR@HOTMAIL.COM  
 
Details of Contact Person
Public Query  
Name  Dr Rajni Mathur  
Designation  Senior Professor 
Affiliation  SMS Medical College Jaipur 
Address  Department of Anaesthesia, Second floor, OT Complex, Dhanwantri building. Sawai Man Singh Medical College and Attached Hospital Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9829357194  
Fax    
Email  Rajnimathur@hotmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Second floor, OT Complex, Dhanwantri building. Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 
 
Primary Sponsor  
Name  Department of AnaesthesiaSawai Man Singh Medical College and Attached Hospital Jaipur 
Address  Department of Anaesthesia Second floor OT Complex Dhanwantri building Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 
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 Rajni Mathur  SMS Hospital Jaipur   Department of Anaesthesia, Second floor, OT Complex,Plastic OT Dhanwantri building. Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN 		 9829357194

RAJNIMATHUR@HOTMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
office of the ethics committee,sms medical college and attached hospitals,jaipur  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  Comparator Group 1 finger grip technique Comparator Group 2 Conventional Pen-Holding Grip Technique   Fingers Grip Technique Intervention Details Endotracheal tube held using fingers grip method during orotracheal intubation. Single-time procedure under standard anaesthesia conditions. 
Intervention  Comparator Group 1 finger grip technique Comparator Group 2Conventional Pen-Holding Grip Technique  Endotracheal tube held using conventional pen-holding grip during orotracheal intubation. Single time procedure under identical conditions. 
Comparator Agent  Conventional Pen-Holding Grip Technique  Conventional Pen-Holding Grip Technique Comparator/Control Details: Participants in this group will perform orotracheal intubation using the Conventional Pen-Holding Grip Technique to hold the endotracheal tube. In this commonly practiced method, the tube is held like a pen between the thumb, index, and middle fingers. The same anaesthetic setup, equipment, and operator conditions will be maintained. Procedure duration: Single-time intervention during intubatio 
Comparator Agent  Group 1 finger grip technique  finger grip Technique Intervention Details: Participants in this group will perform orotracheal intubation using the Fingers Grip Technique to hold the endotracheal tube. In this technique, the tube is held between the thumb, index, and middle fingers, providing improved control and stability during advancement through the vocal cords. All other procedural steps—such as patient positioning, laryngoscope type, anaesthetic technique, and operator experience—will be kept identical to the comparator group. Procedure duration: Single-time intervention during intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient giving written informed consent.
2 Patient undergoing general anaesthesia.
3 Adult patients aged between 18-60 years and both genders.
4 Patients belonging to ASA grade 1 and 2.
5 Patients belonging to Mallampati Grade 1,2 
 
ExclusionCriteria 
Details  1. Patients with cervical spine disease.
2. Patients with anticipated difficult airway.
3. Patients with upper airway abnormalities.
4. Patients with body mass index (BMI more than 35 kg/m?.
5. Patients with high risk of aspiration (hiatus hernia, gastroesophageal reflux dise 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. The mean number of external assistance required during the procedure in the form of
BURP will be documented.
2. Mean time taken for the completion of tracheal intubation by either of the two methods.
3. Mean number of attempts taken.
4. Mean change in Haemodynamic parameters
5. Proportion of patients with complication 		 1. The mean number of external assistance required during the procedure in the form of
BURP will be documented.
2. Mean time taken for the completion of tracheal intubation by either of the two methods.
3. Mean number of attempts taken.
4. Mean change in Haemodynamic parameters
5. Proportion of patients with complication
6.At the time of intubation;
five minutes after intubation,
10 minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
1 hemodynamics changes if any
2 complications if any 		 At the time of intubation;
five minutes after intubation,
10 minutes after intubation 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   04/12/2025 
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="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Thia randamized comparative study aims to evaluate the effectiveness of the fingerts grip techniwue versus the conventional pen holding an endotracheal tube during orotracheal intubation.
participants undergoing elective surgeries ubder general anaesthesia will be randomly assinged to one of the two techniques. the study will compare intubation time ,ease of insertion,success rate and incidence of complications between the two groups. randomization will be computer generated allocation concealed using sealed opaque envelopes and outcome assessment will be performed by a blinded observer. the study will be conducted at SMS Medical College and attached hospitals ,Jaipur.
 
Close