| CTRI Number |
CTRI/2023/11/060374 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of venous blood sample and pulse oxygen saturation with arterial blood sample in critically ill patient |
|
Scientific Title of Study
|
Correlation of Venous blood gas and pulse oximetry with Arterial blood gas in critically ill patients admitted in ICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARITA HANSDA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,RAJENDRA INSTITUTE OF MEDICAL SCIENCES,BARIATU,RANCHI
Ranchi
JHARKHAND
834009
India |
| Phone |
9661120481 |
| Fax |
|
| Email |
saritahansdame@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIO PRIYE |
| Designation |
PROFESSOR |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,RAJENDRA INSTITUTE OF MEDICAL SCIENCES,BARIATU,RANCHI
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
shiopriye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIO PRIYE |
| Designation |
PROFESSOR |
| Affiliation |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,RAJENDRA INSTITUTE OF MEDICAL SCIENCES,BARIATU,RANCHI
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
shiopriye@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI, PIN-834009, JHARKHAND |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIOLOGY RAJENDRA INSTITUTE OF MEDICAL SCIENCES RANCHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES, RANCHI |
| 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 |
| SARITA HANSDA |
RAJENDRA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY, RAJENDRA INSTITUTE OF MEDICAL SCIENCES
Ranchi
JHARKHAND |
9661120481
saritahansdame@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
CRITICALLY ILL PATIENTS ADMITTED IN ICU WITH TREATING DOCTOR ORDERING VBG AND ABG |
|
| ExclusionCriteria |
| Details |
IF PATIENTS HAVE CONTRAINDICATION TO ARTERIAL BLOOD DRAW
PREGNANT PATIENTS
PATIENTS IN SHOCK |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find positive or negative correlation of venous blood gas sample and pulse oximetery with arterial blood gas sample in critically ill patients admitted in ICU
|
Samples to be taken when patient get admitted in ICU and are to be taken as close in time to each other as possible. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate values of pH,pCO2,pO2,HCO3 from arterial & venous blood samples.To determine relation of lactate level in critically ill patients. |
Arterial & venous gas samples to be taken at the same time. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
15/12/2023 |
| 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="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 - NO
|
|
Brief Summary
|
Blood gas analysis is used to asses acid base,ventilation and oxygenation status in critically ill patients.VBG analysis correlate well with ABG. Arterial blood gases(ABG) are more difficult to obtain,more painful.Venous blood gases(VBG) are obtain from venous system and can be obtain along with other blood work.Also,VBG is safe and less invasive than ABG analysis. The primary objective of this study is to correlate between Venous Blood Gas(VBG) and Pulse oximetry with Arterial Blood Gas (ABG) in critically ill patients admitted in ICU. The secondary objective of this study is to correlate values of pCO2,pO2,HCO3 from arterial and venous blood gas samples. Inclusion criteria include critically ill patients admitted in ICU with treating doctor ordering VBG and ABG. Exclusion criteria include patients having contraindication to arterial blood draw,pregnant patients and patients in shock.
|