| CTRI Number |
CTRI/2023/03/050783 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to compare two methods of blood pressure measurement (arterial line & oscillometric cuff) in critically ill patients |
|
Scientific Title of Study
|
Comparison of Noninvasive Oscillometric Blood Pressure with Invasive Arterial Blood Pressure in Critically Ill Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Bharatram |
| Designation |
Academic Registrar |
| Affiliation |
Apollo Hospitals |
| Address |
Critical Care Medicine Department,
Apollo Main Hospital,
Greams Lane,
21, Greams Road,
Thousand Lights,
Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
|
| Fax |
|
| Email |
bharatram.iyer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Venkataraman |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals |
| Address |
Critical Care Medicine Department,
Apollo Main Hospital,
Greams Lane,
21, Greams Road,
Thousand Lights,
Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
|
| Fax |
|
| Email |
ramesh@icuconsultants.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Venkataraman |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals |
| Address |
Critical Care Medicine Department,
Apollo Main Hospital,
Greams Lane,
21, Greams Road,
Thousand Lights,
Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
|
| Fax |
|
| Email |
ramesh@icuconsultants.com |
|
|
Source of Monetary or Material Support
|
| Critical Care Medicine Department,
Apollo Main Hospital,
Greams Lane,
21, Greams Road,
Thousand Lights,
Chennai, Tamil Nadu 600006 |
|
|
Primary Sponsor
|
| Name |
Dr R Bharatram |
| Address |
Critical Care Medicine Department,
Apollo Main Hospital,
Greams Lane,
21, Greams Road,
Thousand Lights,
Chennai, Tamil Nadu 600006 |
| 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 |
| Dr R Bharatram |
Apollo Main Hospital |
Multi Disciplinary Critical Care Unit(MDCCU),
Second Floor, Critical Care Medicine Department,
Main Block
Chennai
TAMIL NADU |
9133913000
bharatram.iyer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-Bio Medical Research, Apollo Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (2) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (3) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (4) ICD-10 Condition: G00-G99||Diseases of the nervous system, (5) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (6) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (7) ICD-10 Condition: K00-K95||Diseases of the digestive system, (8) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (9) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (10) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (11) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (12) ICD-10 Condition: P00-P96||Certain conditions originating in the perinatal period, (13) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, (14) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (15) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All acutely admitted patients of 18 years & older, with an expected ICU stay of at least 24 hours, in whom arterial line has already been placed for medical reasons. |
|
| ExclusionCriteria |
| Details |
Contraindication to cuff application/inflation (e.g., arm injuries, burns or wounds) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the agreement between blood pressure measurements obtained with non-invasive oscillometry (test method) and arterial catheter-derived measurements (reference method). |
The first measurement will be taken within 48 hours of placement of arterial line. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare degree of agreement between two methods separately in patients on high dose vasopressor, low dose vasopressor and patients who are not on vasopressors. |
All the measurements will be taken within 7 days of inclusion in the study |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
Final Enrollment numbers achieved (Total)= "419"
Final Enrollment numbers achieved (India)="419" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2023 |
| Date of Study Completion (India) |
31/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Reference
blood pressure will be measured invasively using an indwelling arterial
catheter placed in the radial artery or femoral artery.
Ø The arterial catheter transducer
will be zeroed (to atmosphere) and levelled (right atrium).
Ø Fast Flush test will be performed to
confirm optimal damping. With optimal damping, the measured pressure
should come to reflect the biological signal within one or two oscillations.
Ø If not optimally damped,
troubleshooting will be done to achieve it. Patient will not be included in the
study if optimal damping cannot be achieved.
Non-invasive
oscillometric blood pressure measurements will be performed using an upper-arm
cuff. (contralateral arm when the arterial line is radial).
Ø Arm circumference will be measured
at the midpoint of acromion & olecranon. The correct cuff size will be
estimated for each patient. The “ideal†cuff should have a bladder length that
is 80% and a width that is at least 40% of arm circumference (a length-to-width
ratio of 2:1)
Ø The cuff will be placed on bare
skin.
Ø If there is an error in noninvasive
oscillometric measurement, that measurement is discarded and new measurement
will be taken after atleast 3 minutes.
The
readings from the monitor (invasive arterial line BP & oscillometric BP)
will be noted at the end of oscillometric BP measurement.
Each pair
of measurements – invasive and oscillometric (Systolic, Diastolic & Mean
Arterial Pressures) – will be taken three times at intervals of three minutes.
The average will be calculated and considered as the result of the measurement.
Multiple
measurements (maximum of 3) may be recorded for each patient at random time
intervals(at least 6 hours apart).
The first
measurement will be taken within 48 hours of placement of arterial line.
All the
measurements will be taken within 7 days of inclusion in the study.
The dose of
vasopressor(s) infusion will be documented at the time of the blood pressure
measurement.
Vasoactive-inotropic
score will be calculated for patients on vasopressor(s) &
inotrope(s)
Once the
sample collection is complete, patients will be categorized based on the median
Vasoactive Inotrope Score (VIS) into the following categories for comparison of
blood pressure measurements
Ø No Vasopressors (VIS = 0)
Ø High dose vasopressors (VIS ≥
Median)
Ø Low dose vasopressor groups (VIS
< Median)
Agreement
between measurements will be defined according to the Association for the
Advancement of Medical Instrumentation (AAMI) standards (mean of the
differences of ≤5 mmHg with a SD of ≤8 mmHg)
Measurements
will be compared using Bland-Altman and Error Grid analyses. |