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CTRI Number  CTRI/2022/01/039161 [Registered on: 05/01/2022] Trial Registered Prospectively
Last Modified On: 04/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Observe change in expired tidal volume with change in endotracheal tube cuff pressure when cuff pressure managed with 2 different method: convential method versus using cuff pressure manometer. 
Scientific Title of Study   Evaluating the convential practice of intraoperative ETT cuff pressure management versus intraoperative management of ETT cuff pressure using pressure manometer on change in expired tidal volume intraoperatively. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemlata kamat 
Designation  Professor, Department of anaesthesiology 
Affiliation  H M Patel center for medical care and education,Pramukhswami medical college, karamsad 
Address  Department of Anaesthesiology,H M Patel center for medical care and education,pramukhswami medical college, karamsad, anand

Anand
GUJARAT
388325
India 
Phone  9909929422  
Fax    
Email  hemlatavk@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr zankruti patel 
Designation  Resident doctor, Department of Anaesthesiology  
Affiliation  H M patel center for medical care and education, Pramukhswami medical college, karamsad, anand 
Address  Department of Anaesthesiology,H M Patel center for medical care and education,pPramukhswami medical college, karamsad, anand

Anand
GUJARAT
388325
India 
Phone  9426399646  
Fax    
Email  zankrutidp@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr zankruti patel 
Designation  Resident doctor, Department of Anaesthesiology  
Affiliation  H M patel center for medical care and education, Pramukhswami medical college, karamsad, anand 
Address  Department of Anaesthesiology,H M Patel center for medical care and education,pPramukhswami medical college, karamsad, anand

Anand
GUJARAT
388325
India 
Phone  9426399646  
Fax    
Email  zankrutidp@charutarhealth.org  
 
Source of Monetary or Material Support  
Shree krishna hospital, pramukhswami medical college, Karamsad, Anand, Gujarat 
 
Primary Sponsor  
Name  Shree krishna hospital 
Address  Shree krishna hospital, Karamsad, Anand, Gujarat 
Type of Sponsor  Private 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 hemlata kamat  shree krishna hospital  Departmentof Anaesthesiology, pramukhswami medical college, shree krishna hospital, karamsad,Anand
Anand
GUJARAT 
9909929422

hemlatavk@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
H M Patel center for medical care and education  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  Endotracheal tube cuff pressure management using pressure cuff manometer and observe change in expired tidal volume.  After intubation, Endotracheal tube cuff will be inflated with help of cuff manometer and intraoperatively cuff pressure will be measured at the interval of 15 mins and if deviated, will be reset at 26cm of H2O. change in expired tidal volume will be noted. duration of study is 12 months, cuff pressure will be noted for complete duration of surgery (1 to 6 hrs) 
Comparator Agent  Endotracheal tube cuff pressure management via convential method of palpating pilot balloon and loss of audible leak around cuff and observe change in expired tidal volume.  After intubation, Endotracheal tube cuff will be inflated by palpation of pilot balloon technique and also look for absence of audible leak around cuff. Intraoperatively cuff will be inflated on the basis of inadequacy of palaption of pilot balloon(not using cuff manometer). change in expired tidal volume will be noted.duration of study is 12 month.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Age: 18 to 60 years,2)Patient with ASA grade I-III physical grade,3)Patient under going general anaesthesia involving use of endotracheal tube, 4)Duration of surgical procedure lasting for 1 to 6 hours
 
 
ExclusionCriteria 
Details  1)Patient with multiple intubation attempts and risk of aspiration,2)Known anatomical laryngotracheal abnormalities.3)General anaesthesia using N2O.4) Surgery requiring flexometallic endotracheal tube.5) Procedure requiring head low position under general anaesthesia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in expired tidal volume.  6 hours(shifting from recovery room) 
 
Secondary Outcome  
Outcome  TimePoints 
1)intra op cuff pressure value
2)intra op ETCo2
3)post op c/o sore throat 
6 hours 
 
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)   11/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Patients who fulfill the eligibility criteria and  requiring general anesthesia and endotracheal intubation will be included in the study. Dragger machine’s leak test will be passed before induction with systemic leak allowed upto 150 ml/min(as per dragger manual). systemic leak more than this will not be allowed. General anesthesia will be induced using intravenous bolus of induction agents and paralysis will be achieved with succinylcholine or a nondepolarizing muscle relaxant. Flow ratio of 1:1 of oxygen and air will be used. Male patient’s trachea will be intubated with an 8 or 8.5 mm internal diameter ETT and female patient’s trachea will be intubated with a 7.0 or 7.5 mm internal diameter ETT ( portex endotracheal tube) endotracheal tube with low pressure high volume will be used. Anesthesia will be maintained with sevoflurane, a volatile anesthetic agent, in a combination of air and oxygen and without nitrous oxide.  Tidal volume will be pre set as 7 ml/kg. Ventilation will be maintained on volume control mode . ETco2 monitoring will be  mandatory and ETco2 will be maintained between 30 to 35mmhg. PEEP will be allowed upto 10cms of H2O. Patient will be maintained in well relaxed state using muscle relaxant(atracurium or vecuronium) in maintenance dose guided by PNS(peripheral nerve stimulaator).  The routine practice in our institution is that endotracheal intubation is done by anesthesiologist and ETT cuff is inflated by the qualified anesthesia technician/ anaesthesia resident . A 10 ml syringe is used to inflate cuff with 6 cc air as a routine in our instititute. Adequacy of cuff inflation is assessed by palpation of pilot balloon as per satisfication of anaesthesiologiest and no audible leak during inspiration.

These patients will be divided into 2 groups: In group 1, endotracheal tube cuff will be inflated manually by trained OT personnel as mentioned above by palpation of pilot balloon technique. Cuff pressure will be measured after inflation of cuff  and than left as it is for rest of surgery. Cuff pressure will be measured at the end of the surgery before extubation prior to giving reversal agent with cuff pressure manometer (portex cuff inflator/pressure  gauge). Intra operatively cuff will be inflated when anaesthesiologiest feel inadequate cuff pressure on palpating pilot balloon and also on the basis of tidal volume, i.e. if more than 10% of the set tidal volume is lost than cuff will be inflated with 10cc syringe till the pre set tidal volume is achieved. In group 2, cuff will be inflated with cuff manometer and cuff  pressure will be set at  26cm of H2O after intubation. Cuff pressure will than be measured at interval of 15 minutes. If cuff pressure is below 20cm of H2O or above 30 cm of H2O, than it will be reset at 26cm of H2O using cuff manometer. Cuff pressure will be measured at the end of the surgery before extubation prior to giving reversal agent . Number of times the cuff pressure required to be adjusted will be noted in both groups. Intra operatively expired tidal volume will be noted  from display of ventilator and Etco2 value will be noted from multipara monitor during each measurment of ET cuff pressure. In this study,each measurement of cuff pressure will be done by same cuff manometer.

 Post operative complain of sore throat will be measured according to complain of patient on basis of 1 to 4 scale at the time of discharge from the recovery room after achieving adequate recovery room discharge score of  9-10.


 
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