| CTRI Number |
CTRI/2024/03/064151 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Other (Specify) [Endotracheal tube intracuff Pressure monitoring] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study of Endotracheal Tube Cuff Pressure and Postoperative Throat Symptoms using Air Versus Saline for Cuff Inflation |
|
Scientific Title of Study
|
A Comparative Study of Endotracheal Tube Cuff Pressure and Postoperative Throat Symptoms using Air Versus Saline for Cuff Inflation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRATIBHA KANE |
| Designation |
Senior consultant in Anaesthesia |
| Affiliation |
Jehangir hospital and Research centre |
| Address |
Department of Anaesthesia.
2nd floor.
Jehangir Hospital and Research Centre.Jehangir Hospital building.32, Sassoon Road.Pune 1.
Jehangir Hospital and Research Centre. Department of anaesthesia. 2nd floor
Jehangir Hospital building.
32, Sassoon Road.Pune 1.
Pune
MAHARASHTRA
411001
India |
| Phone |
9822090771 |
| Fax |
|
| Email |
pratibha.kane@jehangirhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mrs PRATIBHA KANE |
| Designation |
Consultant in Anaesthesia |
| Affiliation |
Jehangir hospital and Research centre |
| Address |
Department of Anaesthesia
2nd floor.
Jehangir Hospital and Research Centre.Jehangir Hospital building.32, Sassoon Road.Pune 1.
Jehangir Hospital and Research Centre. Department of anaesthesia.2nd floor.
Jehangir Hospital building.
32, Sassoon Road.
Pune 1.
Pune
MAHARASHTRA
411001
India |
| Phone |
9822090771 |
| Fax |
|
| Email |
pratibha.kane@jehangirhospital.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATIBHA KANE |
| Designation |
consultant in Anaesthesia |
| Affiliation |
Jehangir hospital and Research centre |
| Address |
Department of Anaesthesia
2nd floor.
Jehangir Hospital and Research Centre.
Jehangir Hospital building.32, Sassoon Road.
Pune 1.
Department of Anaesthesia
2nd floor.
Jehangir Hospital and Research Centre.Jehangir Hospital building.32, Sassoon Road.Pune 1.
Pune
MAHARASHTRA
411001
India |
| Phone |
9822090771 |
| Fax |
|
| Email |
pratibha.kane@jehangirhospital.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pratibha Kane |
| Address |
Jehangir Hospital and research centre. 32 Sassoon Rd. Pune 1.
411001 |
| 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 |
| PRATIBHA KANE |
JEHANGIR HOSPITAL |
Department of Anaesthesia
2nd floor.
Jehangir Hospital and Research Centre.
Jehangir Hospital building.
32, Sassoon Road.
Pune 1.
Pune
MAHARASHTRA |
9822090771
pratibha.kane@jehangirhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JEHANGIR CLINICALDEVELOPMENT CENTRE PVT LTD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Air used in grp A
Saline used in Grp S
|
Comparison of Group A where endotracheal cuff inflation is done with air and Group S where endotracheal tube cuff inflation is done with 0.9% normal saline. Comparison of Cuff pressure measurement using Ambu cuff pressure gauge in 2 groups. The relationship of the cuff pressure to post-operative throat symptoms will be studied and statistically compared. Duration of study is 1 year. Cuff pressures will be noted during the duration of anaesthesia required for the surgery. |
| Intervention |
Comparing endotracheal tube cuff pressures in 2 arms. (Control arm) Group A using Air. (Study arm) Group S using 0.9% normal saline |
Comparison of Group A where endotracheal cuff inflation is done with air and Group S where endotracheal tube cuff inflation is done with 0.9% normal saline. Comparison of Cuff pressure measurement using Ambu cuff pressure gauge in 2 groups. The relationship of the cuff pressure to post-operative throat symptoms will be studied and statistically compared. |
| Comparator Agent |
Saline Vs AIR |
Either Saline or Air is used to inflate endotracheal tube cuff |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing general anaesthesia for more than 1 hour duration. |
|
| ExclusionCriteria |
| Details |
Surgery on head and neck
If patient is a smoker
Use of nitrous oxide as inhalational anesthetic
Patient refusal |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparision of increase in intracuff pressure when saline or air is used for cuff inflation. |
Endo tracheal tube cuff Pressures measured at induction and every hour till extubation. Patient assessed for throat symptoms at 1 hour and at 24 hours after extubation. Patient assessed for throat symptoms at 1hr and 24 hrs after extubation. Correlation of cuff pressures and throat symptoms compared in two groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation of the rise in intracuff pressure & postoperative throat symptoms monitored at 1 hour & 24 hours post extubation. |
Endo tracheal tube cuff Pressures measured at induction & every hour till extubation. Patient assessed for throat symptoms at 1 hour & at 24 hours after extubation. Correlation of cuff pressures & throat symptoms compared in two groups at 1 hour & 24 hours after extubation. |
|
|
Target Sample Size
|
Total Sample Size="348"
Sample Size from India="348"
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)
|
15/04/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total of 348 patients between the age of 18-65 years will be studied. ASA I ( normal healthy person ) and II ( patients with mild systemic disease ) grades undergoing general anaesthesia for greater than 60 minutes duration will be included. An informed written consent will be taken for willingness to participate in this study. Patients will be randomized into two groups , group ’A’ and group ’S’, using a closed envelope method. In group ’A’, endotracheal tube cuff will be inflated with air and in group ’s’, endotracheal tube will be inflated with 0.9% normal saline. 7.0/7.5 mm tube will be used in female patients and 8.0/8.5 mm tube used in male patients. After following all standard protocols for induction, tracheal intubation is performed. No lubricant is applied on the endotracheal tube. The endotracheal tube cuff will be inflated with minimum volume of air or saline required to acheive a seal so as not to have a leak in the circuit. The cuff pressure will be measured using the cuff pressure gauge by Ambu. The cuff pressure will be noted by the investigator after every 60 minutes of the procedure and at the time of extubation.When the cuff pressure is more than 30 cm H2O, it will be noted and adjusted to 25 cm H2O.The incidence and intensity of postoperative throat symptoms like sore throat , cough, hoarseness of voice and dysphagia in both groups will be evaluated using a questionnaire by nurses in the PACU at 1 hour and at 24 hours by the ward nurses. |