| CTRI Number |
CTRI/2024/12/077784 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the position of windpipe tube cuff and outcomes in children requiring artificial ventilatory support |
|
Scientific Title of Study
|
Position of cuff of Microcuff Endotracheal Tube in Critically ill Children requiring Mechanical Ventilation and their outcomes - A Prospective Observational Study |
| 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 Pankaj Kundra |
| Designation |
Professor (Senior Administrative Grade)) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296161 |
| Fax |
|
| Email |
pankajkundra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kundra |
| Designation |
Professor (Senior Administrative Grade)) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry
PONDICHERRY
605006
India |
| Phone |
04132296161 |
| Fax |
|
| Email |
pankajkundra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthilnathan Muthapillai |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598566983 |
| Fax |
|
| Email |
mmc.senthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Dhanvantri nagar,
Puducherry-605006. |
| Type of Sponsor |
Government 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 Pankaj Kundra |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Paediatric Intensive Care Unit, First floor,
WCH block, JIPMER, Dhanvantri nagar, Puducherry-605006
Pondicherry
PONDICHERRY |
04132296161
pankajkundra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Observational Studies DHR REG. NO. EC/NEW/INST/2020/331 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T175||Foreign body in bronchus, (2) ICD-10 Condition: J09X||Influenza due to identified novelinfluenza A virus, (3) ICD-10 Condition: I279||Pulmonary heart disease, unspecified, (4) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 1 year to 11 years intubated with microcuff endotracheal tube and requiring mechanical ventilation at least for 24 hours will be included in this study. |
|
| ExclusionCriteria |
| Details |
Following children will be excluded from this study:
1. Children requiring reintubation due to any cause after extubation
2. Children with known airway anomalies
3. Children with a diagnosis of croup / TB / suppurative
focus in the head and neck prior to intubation.
4. Children who undergo tracheostomy while on ventilator
5. Children with subcutaneous emphysema of the neck
6. Children with chronic CNS disease like cerebral palsy,
neuro regression etc
7. Children with superior mediastinal syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of children (age 1-11 years) on mechanical ventilation who have the cuff of microcuff endotracheal tube positioned at the level of the cricoid for at least 24 hours during the period of mechanical ventilation |
USG imaging of the position of the cuff will be studied once every day from day 2 of mechanical ventilation till 7 days or till extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the duration in days in which the cuff of the microcuff endotracheal tube is positioned at the level of the cricoid during the entire period of mechanical ventilation in the recruited children |
USG imaging of the position of the cuff will be studied once every day from day 2 of mechanical ventilation till 7 days or till extubation |
| To study the proportion of children with upper limit of cuff at the levels of 1st, 2nd and 3rd tracheal rings |
USG imaging of the position of the cuff will be studied once every day from day 2 of mechanical ventilation till 7 days or till extubation |
| To compare the Proportion of children with extubation failure (defined as reintubation within 48 hours) between the children in whom the microcuff is positioned at the level of cricoid for at least 24 hours during mechanical ventilation with those in whom the cuff was never positioned at the level of cricoid for 24 hours. |
From the time of extubation till 48 hours after extubation |
| To compare the frequency of occurrence of stridor (as assessed by Wesley stridor score) between the children in whom the micro cuff is positioned at the level of cricoid for at least 24 hours during mechanical ventilation with those in whom the cuff was never positioned at the level of cricoid for 24 hours. |
from the time of extubation till 48 hours after extubation |
| To compare the frequency of occurance of airway oedema between the children in whom the micro cuff is positioned at the level of cricoid for at least 24 hours during mechanical ventilation with those in whom the cuff was never positioned at the level of cricoid for 24 hours. |
From the time of extubation till 7 days after extubation |
To determine the duration in days in which the cuff of the micro cuff endotracheal tube is positioned at the level of the cricoid during the entire period of mechanical ventilation in the recruited children
|
USG imaging of the position of the cuff will be studied once every day from day 2 of mechanical ventilation till 7 days or till extubation |
|
|
Target Sample Size
|
Total Sample Size="227"
Sample Size from India="227"
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)
|
10/02/2025 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pankajkundra@gmail.com].
- For how long will this data be available start date provided 26-08-2027 and end date provided 26-09-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After obtaining the approval from JSAC and IEC, JIPMER, this study will be registered in Clinical Trials Registry-India (CTRI). Children aged between 1 year to 11 years requiring mechanical ventilation in PICU, JIPMER and meeting the inclusion criteria will be recruited in this study. Written informed consent will be obtained from the legally acceptable representative (LAR) of the recruited children. The placement of the microcuff ETT will be confirmed by visualizing the passage of the tube between the vocal cords using a laryngoscope. The microcuff ETT will be fixed at the angle of the mouth on the right side after ensuring bilateral equal air entry in the lungs. All recruited children will be ventilated with a tidal volume of 6 to 8 ml.kg-1 of ideal body weight (IBW). The difference between the inhaled and exhaled tidal volumes (VT) will be compared. If the difference between the inhaled and exhaled VT is <10%, then the cuff will not be inflated. If the difference between exhaled VT and inhaled VT is >10%, then the microcuff will be inflated in increments of 0.5 ml of air until the difference falls to <10% between the inhaled and the exhaled VT. The pressure inside the microcuff will be monitored with a cuff pressure monitor every day and will be noted. USG of the airway will be performed to locate the position of the microcuff in the trachea and the image will be saved. This imaging will be performed once per day from day 2 of initiation of mechanical ventilation to till their extubation or until day 7 of mechanical ventilation. If the cuff of ETT is positioned at the level of the glottis, the ETT will repositioned to make sure the cuff is below the level of glottis. Children requiring mechanical ventilation for more than 7 days will be withdrawn from this study. If any child requires reintubation within 48 hours of extubation, it will be considered as extubation failure. Number of children developing stridor after extubation will be noted. The children who require reintubation will be intubated with videolaryngoscope and any edema of the airway (false cords, true cords) will be noted.
|