| CTRI Number |
CTRI/2020/11/029035 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
03/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Compare oxygen saturation from pulse oximetry and ABG in COVID-19 patients in ICU/HDU |
|
Scientific Title of Study
|
An observational study of simultaneous pulse oximetry and arterial oxygen saturation readings in intensive care unit / high dependency unit in COVID -19 patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadia Rose |
| Designation |
Assistant professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anesthesiology
Rajarajeshwari medical college
Mysore road
Kambipura 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nadia Rose |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeshwari Medical college and hospital |
| Address |
Department of Anesthesiology
Rajarajeshwari Medical college
Mysore road
Kambipura 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramya B Sriram |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology,RRMCH |
| Address |
Junior Resident
Dept.Of Anaesthesia
Rajarajeshwari Medical college and Hospital
Kambipura-560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9886617218 |
| Fax |
|
| Email |
ramyabsriram6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari Medical College and Hospital,Kambipura,Bangalore-560074 |
|
|
Primary Sponsor
|
| Name |
Nadia Rose |
| Address |
Assistant professor
Dept. of Anesthesiology
Rajarajeshwari Medical College and Hospital
Kambipura,Karnataka |
| 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 |
| Nadia Rose |
Intensive Care Unit,High dependency Unit,Rajarajeshwari medical college and hospital |
Mysore Road
Kambipura-560074
Bangalore
KARNATAKA |
9513454567
dr.nadia.rose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeshwari Medical College and Hospital- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Covid- 19 positive patients of age more than or equal to 18yrs and less than or equal to 80 years admitted to ICU/HDU |
|
| ExclusionCriteria |
| Details |
Age less than 18yrs and more than 80yrs
Diagnosis of methemoglobinemia
Painted nails(nail polish)
History of smoking
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To examine the relationship between SpO2 (oxygen saturation as measured by pulse oximeter) and SaO2 (oxygen saturation measured by arterial blood gas analysis) measurements in COVID19 patients admitted to ICU/HDU.
|
During ICU/HDU admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the ability of SpO2 readings to detect low SaO2 and low Oxygen tension (PaO2) in COVID 19 patients.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
Knowing the relationship between SpO2, SaO2 and PaO2 will greatly help in timely oxygen therapy for COVID-19 patients.So this observational study will be conducted in patients admitted to intensive care unit and high dependency units due to Covid related complications.
Covid -19 positive patients admitted in ICU/HDU will be provided routine pulse oximeter monitoring and ABG (arterial blood gas) sampling will be performed in usual clinical case. Patients who are younger than 18 and more than 80 years will be excluded.Patients with a diagnosis of methemoglobinemia, history of smoking, and with nail polish will also be excluded from the study. The primary objective will be to see if there is any discrepancy between the oxygen saturation as measured from arterial blood gas sampling and pulse oximeter in Covid-19 positive patients.The ability of SpO2 to detect low SaO2 and low PaO2 in COvid-19 patients will be assessed. Factors which could potentially affect the accuracy of pulse oximeter will be documented. |