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
|
|
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
|
|
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.
|