FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024496 [Registered on: 07/04/2020] Trial Registered Prospectively
Last Modified On: 27/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Making the endotracheal tube patient friendly  
Scientific Title of Study   Comparison of post extubation complications with use of air versus normal saline versus lignocaine for endotracheal tube cuff inflation  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudhakar B 
Designation  Professor 
Affiliation  Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation  
Address  Department of anaesthesiology Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation Chinnavutupalli, Gannavaram

Krishna
ANDHRA PRADESH
521286
India 
Phone  9440174928  
Fax    
Email  sudhakarbillapati@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudhakar B 
Designation  Professor 
Affiliation  Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation  
Address  Department of anaesthesiology Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation Chinnavutupalli, Gannavaram

Krishna
ANDHRA PRADESH
521286
India 
Phone  9440174928  
Fax    
Email  sudhakarbillapati@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rachana Nagubandi 
Designation  Post graduate 
Affiliation  Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation  
Address  Department of anaesthesiology Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation Chinnavutupalli, Gannavaram

Krishna
ANDHRA PRADESH
521286
India 
Phone  6302333013  
Fax    
Email  rachana.manipal95@gmail.com  
 
Source of Monetary or Material Support  
Dr Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation,Chinnavutupalli, Andhra Pradesh 521101.  
 
Primary Sponsor  
Name  Dr Pinnamaneni Siddhartha Institue of Medical Sciences and Research Foundation  
Address  Chinnavutupalli, Andhra Pradesh-521286  
Type of Sponsor  Research institution and hospital 
 
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 Sudhakar B  Department of Anaesthesiology and critical care  Department of Anaesthesiology and critical care, Second floor OT, Dr PINNAMANENI SIDDHARTHA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH FOUNDATION, CHINAOUTAPALLI, ANDHRA PRADESH, 521101.
Krishna
ANDHRA PRADESH 
9440174528

sudhakarbillapati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR PSIMS AND RF IEC Human Studies  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  air 4-6cc,normal saline 4-6cc,lignocaine 4-6 cc  Endotracheal tube cuff inflated with air or normal saline or lignocaine during intubation to maintain the cuff pressure at 20-30 cm of water and after extubation, complications like hoarseness,sore throat,cough etc with various agents will be assesed 
Intervention  endotracheal tube cuff inflation after intubation  Endotracheal tube cuff inflated with air or normal saline or lignocaine during intubation to maintain the cuff pressure at 20-30 cm of water and after extubation, complications like hoarseness,sore throat,cough etc with various agents will be assesed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of anaesthesiology grade 1 and 2
Mallampati all grades
BMI 18.5-24.9 
 
ExclusionCriteria 
Details  Patients with prior respiratory tract infections
Patients with prior throat discomfort
Patients with prior hoarseness
Pregnant women
Patients with nasogastric tube
More than one attempt intubation  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Better tolerable endotracheal intubation with decreased incidence of post operative sore throat and cough   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/04/2020 
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="1"
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)?  

Brief Summary  

Smooth emergence has always been the desire of every anaesthesiologist, and also recently, anesthesiologists have been actively participating in the postoperative care, which brings into light the importance of the most common post-extubation complication that is sore throat.

 Various methods have been identified to alleviate these complications.

Among all those, one of the simplest measure is cuff pressure maintenance and delivery of a local anesthetic via diffusion during the maintenance period.

 This study emphasizes the importance of an initial step (inflation of endotracheal tube cuff) taken while induction and its effect on post-extubation complication and compares various agents with the routinely used agent (air) with an aim to identify the better agent in providing the post-operative care.

The study will be conducted in a double-blinded manner using color-coding given by the statistician for the researcher for different agents, which allows the patient and the researcher to be unaware of the agent used by means of sealed envelopes each containing the consent form, agent, the monitoring chart for data collection.

After taking informed consent the patients are appropriately premedicated, pre oxygenated, induced, and an appropriate muscle relaxant will be given and after intubation with the suitable size polyvinyl chloride cuffed endotracheal tube an agent from one of the groups will be used for inflation of the cuff until ideal cuff pressure is obtained without the cuff leak.

Appropriate amounts of air or normal saline or lignocaine is inflated into the to achieve ideal cuff pressure.

 

Various objective parameters like  hemodynamic parameters including heart rate, respiratory rate, blood pressure, SpO2, ETCO2 and cuff pressure and the volume of the agent added or removed for maintenance of the ideal cuff pressure are recorded before the usage of nitrous oxide and every 15 minutes during the entire procedure and another measurement before turning off the nitrous oxide and another final reading of the parameters just before extubation.

Subjective parameters, including sore throat and coughing during extubation, are objectified by using a visual analog scale and binary system (yes/no), respectively.

  Presence of sore throat is also assessed on postoperative day one (24 hours assessment)

The data collected will be delivered to the statistician in a master chart prepared according to the alphabet coding not known to the statistician




 
Close