| CTRI Number |
CTRI/2024/09/073752 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Relationship Between End-Tidal and Arterial Carbon Dioxide in Mechanically Ventilated Children: A Comparative Analysis |
|
Scientific Title of Study
|
Correlation of End tidal and Arterial carbon dioxide in mechanically ventilated children |
| 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 Ganesh kolur |
| Designation |
Postgraduate Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Paediatrics Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9740989947 |
| Fax |
|
| Email |
Ganesh.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar B K |
| Designation |
MD Paediatrics, Associate Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Paediatrics Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8197120018 |
| Fax |
|
| Email |
kumar.sandeep@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Pai |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Paediatrics Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8970210500 |
| Fax |
|
| Email |
megha.pai@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Tiger circle road,Madhav nagar,Eshwar nagar,
Manipal,Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 Ganesh Kolur |
Kasturba Medical College and Hospital |
Women and Children
block, Department of
Paediatrics, Kasturba Medical College,
Madhav Nagar, Manipal-576104, Udupi,Karnataka,
Udupi
KARNATAKA |
9740989947
ganesh.kmcmpl2023@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Mechanically ventiated children from 1 month to 18 years admitted to PICU in whom ABG is done, Department of Paediatrics, Kasturba Medical College, Manipal |
|
| ExclusionCriteria |
| Details |
children with significant ventilator circuit leak as detected by difference in inspiratory and expiratory tidal volume or in volume - time graph
2) children with tracheostomy
3)Cyanotic congenital heart disease or with significant right to left intracardiac shunt
4)Venous blood samples will not be included in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the reliability of Etco2 to predict
Paco2 in mechanically ventilated children admitted to paediatric Intensive Care Unit |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the relationship of PaCo2 & ETCO2 On parameters affecting oxygenation & ventilation |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
10/09/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
All intubated children with post intubation Xray will be assessed for eligibility. Informed Consent will be obtained from the parents of the study participants ,Children who Satistied inclusion criteria will be taken up for the study. Indication for ICU admission and mechanical ventilation will be noted . Whenever Arterial blood gas done as a part of standard protocol of treatment, simultaneously Etco2 will be recorded. Continuous mainstream Etco2 monitoring probe, Philips Capnostat M2501A gas analyser will be attached to endotracheal tube for recording Simultaneous Etco2 and PaCo2 measurements will be recorded in a bedside datasheet. At least two readings will be taken from each patient with a minimum gap of 24 hours as a part of standard protocol of treatment , these values help in assessment of patient status and guide in further management. At the time of data collection, the following ventilator parameters will be recorded: Respiratory rate, Fractional inspired oxygen concentration (Fio2), expiratory tidal volume, peak inspiration pressure (PIP), positive end-expiratory pressure (PEEP), Oxygen saturation(spo2). Inspiratory time (Ti) and I:E ratio. Severity of lung disease will be calculated using Ventilation index (VI), Oxygenation Index and P/F ratio. PF ratio will be calculated using the formula Pao2/Fio2, where Pao2 is Partial pressure of arterial Oxygen tension, Fio2 is Fraction of inspired Oxygen. PIF ratio <200 is considered as abnormal. Ventilation index will be calculated using equation VI = (Paco2 X PIP]X RR, where paco2 is partial pressure of co2 and PIP is Peak inspiratory pressure, RR is respiratory rate of mechanical ventilator VI for > 20 is considered as high. Oxygenation Index: Ol= FIO2 X MAP/Paco2 (Mean airway pressure) Ol >16: Severe ARDS. data obtained will be analysed using the Statistical Package for Social Sciences (SPSS) version 23.0. Descriptive will be expressed as frequencies and percentages. Mean and standard deviation will be computed for the variables following normal distribution curve while median and inter-quartile range will be Computed for nonparametric data Fisher exact test will be used to test categorical variables. Student t-test or Mann Whitney test will be used to compare mean or median value of parameter between 2 groups. Pearson bivariate Correlation will be used to study the linear correlation, Coefficient of determination will be calculated by applying the linear regression with Paco2 as the dependent and Etco2 as the independent variable The cut-off p-value for the significance test will be <0.05 |