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
|
|
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
|
|
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
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