| CTRI Number |
CTRI/2024/05/067762 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Monitoring the pressure of cuff in artificial tube placed in wind pipe of ventilated children |
|
Scientific Title of Study
|
Monitoring endotracheal cuff pressure in mechanically ventilated children admitted to Pediatric Intensive Care unit |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahana S Nayak |
| Designation |
Post graduate student |
| Affiliation |
Manipal college of Health Professions |
| Address |
4th floor
Department of Respiratory Therapy
Manipal college of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576107
India |
| Phone |
8296375034 |
| Fax |
|
| Email |
sahana.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sandeep Kumar |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Paediatrics, Kasturba Medical college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197120018 |
| Fax |
|
| Email |
kumar.sandeep@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sahana S Nayak |
| Designation |
Post graduate student |
| Affiliation |
Manipal college of Health Professions |
| Address |
4th floor
Department of Respiratory Therapy
Manipal college of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576107
India |
| Phone |
8296375034 |
| Fax |
|
| Email |
sahana.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sahana S Nayak |
| Address |
4th floor
Department of Respiratory Therapy
Manipal college of Health Professions
Manipal Academy of Higher Education
Manipal |
| 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 |
| Sahana S Nayak |
Kasturba Hospital, Manipal |
Department of Paediatrics,
Second floor, Paediatric Intensive Care Unit, KMC, Manipal.
Udupi
KARNATAKA |
8296375034
sahana.mchpmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J13||Pneumonia due to Streptococcus pneumoniae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children intubated with cuffed endotracheal tube from 1 month to 18 years of age and children who need invasive mechanical ventilation |
|
| ExclusionCriteria |
| Details |
Children intubated with uncuffed endotracheal tube, children who underwent tracheostomy and parent denied the consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of endotracheal cuff under inflation and over inflation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in endotracheal cuff pressure associated with position change after suctioning or any other procedures |
Baseline |
|
|
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)
|
01/06/2024 |
| 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="0"
Months="8"
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
|
This study is a observational study to monitor endotracheal cuff pressure in mechanically ventilated children admitted to Pediatric Intensive Care Unit. This study will be conducted for 8 months in Pediatric Intensive Care Unit, Kasturba Hospital , Manipal. The primary outcome measured will be the incidence of endotracheal cuff underinflation and overinflation and the secondary outcome will be change in endotracheal cuff pressure associated with position change after suctioning or any other procedures. |