| CTRI Number |
CTRI/2023/05/053106 [Registered on: 24/05/2023] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Connection between the amount of carbon dioxide in the arterial blood and the carbon dioxide exhaled by patients who are intubated for respiratory failure due to low oxygen. |
|
Scientific Title of Study
|
Correlation between the partial pressure of arterial carbon dioxide
and the partial pressure of end-tidal carbon dioxide in hypoxemic respiratory failure
patients on invasive mechanical ventilation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Sharma |
| Designation |
M.Sc. Respiratory Therapy (Adult) |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Respiratory therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8077300562 |
| Fax |
|
| Email |
garima1.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pratibha Todur |
| Designation |
HOD (Incharge) |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Respiratory therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095103671 |
| Fax |
|
| Email |
pratibha.todur@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Pratibha Todur |
| Designation |
HOD (Incharge) |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Respiratory therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095103671 |
| Fax |
|
| Email |
pratibha.todur@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Garima Sharma |
Kasturba Hospital, Manipal |
ICU1 and ICU2 Intensive care unit, Manipal,
Udupi
KARNATAKA |
8077300562
garima1.mchpmpl2022@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: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with hypoxemic respiratory failure
receiving invasive mechanical ventilation. |
|
| ExclusionCriteria |
| Details |
Patients on non-invasive ventilation and tracheostomy. Patients intubated due to COPD and asthma and neuro-muscular disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between PaCO2 (mmHg) and PETCO2 (mmHg). |
Once after intubation at the time of first ABG. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of PaCO2 and PETCO2 across different levels of hypoxia measured by PaO2/FiO2 ratio |
Once after intubation at the time of first ABG. |
|
|
Target Sample Size
|
Total Sample Size="185"
Sample Size from India="185"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2023 |
| Date of Study Completion (India) |
31/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a prospective cross sectional observational study, comparing the partial pressure of arterial vs end tidal carbon dioxide in intubated patients with hypoxemic respiratory failure in 185 patients that will be conducted in critical care unit of Kasturba Hospital, Manipal. The primary outcome will be correlation between PaCO2 and PETCO2. The secondary outcome will be correlation of PaCO2 and PETCO2 across different levels of hypoxia measuured by PaO2/ FiO2 ratio. |