| CTRI Number |
CTRI/2024/06/068601 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of tracheal suctioning on cuff pressure of ventilator patients in ICU |
|
Scientific Title of Study
|
Effect of tracheal suctioning on cuff pressure in mechanically ventilated sedated patients in ICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anoop Mesiah Das |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical Collage ,Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical Collage
Lighthouse Hill Road
Mangalore
Manipal Academy of Higher Education
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9947208048 |
| Fax |
|
| Email |
anoop.kmcmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Bhat |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical Collage ,Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical Collage
Lighthouse Hill Road
Mangalore
Manipal Academy of Higher Education
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9980014995 |
| Fax |
|
| Email |
sonal.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Bhat |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical Collage ,Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical Collage
Lighthouse Hill Road
Mangalore
Manipal Academy of Higher Education
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9980014995 |
| Fax |
|
| Email |
sonal.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical Collage,
Manipal Academy Of Higher Education, Mangalore,Karnataka,India 575001 |
|
|
Primary Sponsor
|
| Name |
Dr Anoop Mesiah Das |
| Address |
Department of Anaesthesiology
Kasturba Medical Collage
Lighthouse Hill Road
Mangalore
Manipal Academy of Higher Education
575001
|
| Type of Sponsor |
Other [Self] |
|
|
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 Anoop Mesiah Das |
Kasturba Medical Collage Hospitals |
Department of Anaesthesiology
Kasturba Medical Collage
Lighthouse Hill Road
Mangalore
Manipal Academy of Higher Education
575001
Dakshina Kannada
KARNATAKA |
9947208048
anoop.kmcmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Medical Collage ,Mangalore |
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 |
nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are mechanically ventilated for more than two days.
2.An appropriate level of sedation scoring -4 or -5 on the Richmond Agitation sedation Scale |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in study.
2.Pregnant and agitated patients.
3.Patients with BMI more than 30 |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of cuff pressure before and after suctioning and measure the hemodynamic parameters Heart Rate, Blood pressure,SPO2. |
Baseline
0 minutes
30 minutes
60 minutes
2 hours
4 hours
6 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To list out the complication of change in cuff pressure due to suctioning |
0 minutes to 6 hours post Suctioning |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
18/06/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Endotracheal tube cuff pressure must be kept in an optimal range but can get changed .if the cuff pressure is out of the normal range can cause insufficient ventilation , mucosal irritations and microaspiration. This study is aimed to determine the effect of suctioning on cuff pressure in mechanically ventilated sedated patients in ICU.
Objectives 1.To compare the endotracheal cuff pressure before and after suctioning in mechanically ventilated patients .2.To list out complications post suctioning irrespective of cuff pressure.
Maintaining a constant cuff pressure within the limit is required to reduce the complications in intubated patients.Continuous cuff pressure monitoring helps in maintaining the cuff pressure in recommended limit, hence reducing the airway related complication . |