FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/04/013003 [Registered on: 04/04/2018] Trial Registered Retrospectively
Last Modified On: 25/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of the pressure of the cuff in the oral respiratory tube using two different techniques under general anesthesia during surgical procedures 
Scientific Title of Study   Comparison of endotracheal tube cuff pressures using manual vs. pressure gauge monitored technique 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alka Hasmukhbhai Bhoot 
Designation  MD Anesthesia (second year resident) 
Affiliation  Government medical college and New civil hospital Surat 
Address  23, Ratnasagar society, Spinning mill road, Kapodara, Surat
Department of Anesthesiology, 1st/2nd floor, Operation theatre complex, New civil hospital, Majura Gate, Surat-395001.
Surat
GUJARAT
395006
India 
Phone  9033126010  
Fax    
Email  alkabhoot@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemangini Manish Patel 
Designation  Assistant Professor 
Affiliation  Government medical college and New civil hospital, Surat 
Address  9/C, Prerna Apartment, Ravishankar Sankul, Bhatar char rasta, Surat
1st/2nd Floor, Operation Theatre Complex, Department of Anesthesiology, New Civil Hospital, Majura Gate, Surat-395001.
Surat
GUJARAT
395017
India 
Phone  9408709807  
Fax    
Email  dr26hemanginisurat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Alka Hasmukhbhai Bhoot 
Designation  MD Anesthesia (Second year resident) 
Affiliation  Government medical college and New civil hospital, Surat 
Address  23, Ratnasagar society, Spinning mill road, Kapodara, Surat
1st/2nd floor, operation theatre complex, department of anesthesiology, New civil hospital, majura gate, Surat-395001
Surat
GUJARAT
395006
India 
Phone  9033126010  
Fax    
Email  alkabhoot@yahoo.co.in  
 
Source of Monetary or Material Support  
New Civil Hospital, Surat 
 
Primary Sponsor  
Name  Dr Alka Hasmukhhai Bhoot 
Address  23, Ratnasagar society, Spinning mill road, Kapodara, Surat - 395006 
Type of Sponsor  Other [Principal investigator herself is a primary sponsor] 
 
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 Alka Hasmukhbhai Bhoot  New Civil Hospital, Surat  First & Second floor, Operation theatre complex, Department of Anesthesiology, Government Medical College, Majura Gate, Surat - 395001
Surat
GUJARAT 		 9033126010

alkabhoot@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Research Ethics Committee, Government Medical College and New Civil Hospital, Surat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA Class 1,2 and 3 patients scheduled for any elective surgical procedure under general anesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C Inflation of ETT cuff via manometer  Inflation of ETT cuff via manometer aided by direct intra cuff pressure measurement. 
Intervention  Group M Inflation of ETT cuff by a syringe  Inflation of ETT cuff by a syringe with estimation of intra cuff pressure by manual palpation of pilot balloon and by auscultation with a stethoscope by an experienced anaesthetist (with an experience of at least three years) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) Age: 18-75 years
2) Gender: male and female
3) ASA Class: 1, 2, 3
4) Patients posted for routine surgery, without any risk of aspiration or regurgitation requiring general anesthesia with orotracheal intubation
5) Duration of surgery less than 4 hours
6) Two or less than two attempts of intubation
 
 
ExclusionCriteria 
Details  1) Prone/lateral positioning for surgery
2) Recent history of upper respiratory tract infections; preoperative sore throat, hoarseness of voice or cough
3) Tracheostomised patients
4) Known airway anomalies (airway stenosis, including Down’s syndrome)
5) Known or suspected difficult intubation
6) Head and neck surgeries like surgery of the larynx and/or of the trachea, neck, and/or upper oesophagus
7) Pulmonary diseases (concurrent pneumonia or bronchial infection, asthma requiring inhalation medication, pulmonary malformations)
8) Fibre-optic intubation or alternative intubation technique
9) Planned postoperative ventilation in the ICU
10) Patients at risk of aspiration - Pregnant patients, full stomach.
11) Anterior cervical spine surgeries.
12) Patients having hypotension (BP< 90 mm Hg)
13) Patients with BMI > 35 kg/m2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary aim:
1) To compare endotracheal cuff pressures obtained by- manual inflation of pilot balloon (by a syringe) and direct inflation via a cuff pressure gauge.
2) To evaluate changes in cuff pressure over time.
 		 1. just after intubation
2. at 30 mins
3. at 1 hour
4. at 2 hours
5. at 3 hours
6. at 4 hours/ just before extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary aim:
To assess complications like sore throat, hoarseness of voice, cough, post extubation stridor which may occur as a result of overinflated ETT cuff; aspiration which may occur as a result of insufficiently inflated cuff.
 		 secondary outcome observed after 2 hours and 24 hours after extubation 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/06/2015 
Date of Study Completion (India) 15/11/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/11/2017 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published in any journal. Presented as an E-poster in Gujarat ISACON (GISACON) 2016 (conducted at Bhavnagar, Gujarat) under randomized control trial category. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The main function of an endotracheal tube (ETT) cuff is to maintain adequate sealing of airway, prevent gastro pharyngeal contents aspiration and ensure effective lung ventilation. One aspect of airway management is maintenance of an adequate pressure in the ETT cuff. A cuff pressure between 20 and 30 cm H2O is recommended to provide an adequate seal and reduce the risk of complications.  The minimal occlusive intracuff pressure required for positive pressure ventilation, to prevent aspiration is approximately 20 cm H2O. Cuff pressure should not be more than 25 cm H2O (20-30 cm H2O) to maintain tracheal mucosa perfusion and thereby prevent mucosal ischemia, tracheal necrosis, rupture, stenosis, laryngeal nerve palsy and tracheoesophageal fistula. Endotracheal tube cuff pressure is usually not routinely measured and previous studies have demonstrated that cuff palpation is insufficient to detect high cuff pressure. Adequacy of ETT cuff inflation is usually checked by one of the following techniques: Manual palpation of the pilot balloon, disappearance of audible air leak through the mouth or the use of either an aneroid manometer (manual pressure gauge) or continuous automatic ETT cuff pressure controller. In the present study we will compare the endotracheal cuff pressure obtained via direct manual palpation of pilot balloon - with direct measurement via a Mallinckrodt cuff pressure gauge.From our study we found that -

·         The endotracheal tube cuff pressure increase gradually with time, especially with use of nitrous oxide. This rise can occur even with shorter duration surgeries, as was the case with our study.

·         There is a rise in endotracheal tube cuff pressure even when manometer was first used for inflation of ETT cuff.

·         Only 78% of experienced anesthetist could maintain the cuff pressure within the recommended range which shows that manual estimation techniques cannot be relied upon.

·         A decrease in incidence of complications was noted in the control group (group C), where a manometer was used. Thus, intubation related morbidities can be reduced by doing vigilant monitoring of the intracuff pressure throughout the duration of intubation.

 

            Thus, we conclude and recommend that endotracheal tube cuff inflation and frequent monitoring of the endotracheal tube cuff pressure by a simple tool like cuff pressure manometer should be introduced as a standard of practice.

 

 
Close