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CTRI Number  CTRI/2020/12/029991 [Registered on: 23/12/2020] Trial Registered Prospectively
Last Modified On: 22/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison between endotracheal cuff inflation techniques and post operative laryngotracheal complaints 
Scientific Title of Study   A comparative study of post operative laryngotracheal morbidity on endotracheal cuff inflation techniques - a longitudinal study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jinu Joy 
Designation  Post graduate trainee 
Affiliation  Amala institute of medical sciences,Thrissur 
Address  Department of anesthesiology Devamatha Annexe, Room 502 Amala institute of medical sciences, Amalanagar p.o Thrissur, Kerala

Thrissur
KERALA
680555
India 
Phone  8547592473  
Fax    
Email  jinu922004@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajagopal P 
Designation  Associate Professor 
Affiliation  Amala Institute of Medical Sciences, Thrissur 
Address  Department of anesthesiology Amala Institute of Medical Sciences, Amalanagar p.o, Thrissur, Kerala

Thrissur
KERALA
680555
India 
Phone  9995555239  
Fax    
Email  rajagopaltall@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jinu joy 
Designation  Post graduate trainee 
Affiliation  Amala Institute of Medical Sciences, Thrissur 
Address  Department of anesthesiology Devamatha Annexe, room 502 Amala Institute of Medical Sciences, Amalanagar p.o, Thrissur, Kerala

Thrissur
KERALA
680555
India 
Phone  8547592473  
Fax    
Email  jinu922004@gmail.com  
 
Source of Monetary or Material Support  
Amala institute of medical sciences, Thrissur 
 
Primary Sponsor  
Name  Dr Jinu Joy 
Address  Devamatha Annexe, Amala Institute of Medical Sciences, Amalanagar p.o, Thrissur, Kerala 
Type of Sponsor  Other [Myself] 
 
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 Jinu Joy  Operation theatre, Department of Anaesthesiology  Amala institute of Medical Sciences, Amalanagar p.o, Thrissur, Kerala
Thrissur
KERALA 		 8547592473

jinu922004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  undergoing elective surgeries under general anesthesia 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endotracheal cuff inflation techniques   ETT cuff will be inflated by one of the following methods following intubation-Just seal method, constant pressure method and stethoscope guided method 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Undergoing elective surgeries of less than 180 minutes duration 
 
ExclusionCriteria 
Details  Patients undergoing head and neck surgery,
Patients with tracheostomy,
More than 2 attempts at intubation – anticipated difficult airway,
Use of nasogastric tube or throat packs,
Patients with upper respiratory tract infection
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative laryngotracheal morbidity on three different endotracheal cuff inflation techniques - Just seal method, constant pressure method and stethoscope guided method. And to assess the incidence of post intubation airway complications like sore throat, cough, hoarseness, dysphonia  Cuff volume in noted at the time of induction and cuff volume out measured before extubation and intracuff pressure will be monitored hourly throughout intraoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the incidence of post intubation airway complications like sore throat, cough, hoarseness, dysphonia  the above mentioned will be monitored for 24 hours postoperatively at 1 hour, 6 hour and 24 hour intervals. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   24/12/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   In this study, we will compare three different endotracheal cuff inflation techniques that is Just Seal method, Constant pressure method and Stethoscope guided method to that of post operative laryngotracheal morbidity. We will also assess the incidence of post intubation complications which occurred among the three groups. This is a longitudinal study which includes three groups of 18 patients each who were ASA I-II with similar demographic profile, aged 18 to 60 years, undergoing elective surgeries under general anesthesia. They will be intubated with ETT cuff inflated by one of the methods based on computer based randomization. Post operatively following will be monitored for 24 hours - sore throat, cough, restlessness, dysphonia and post operative nausea vomiting. 
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