| CTRI Number |
CTRI/2025/04/085821 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accuracy of plethysmography derived blood pressure |
|
Scientific Title of Study
|
Accuracy of plethysmography derived blood pressure -A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kushi TS |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of anaesthesia and ot technology, KS Hegde medical academy, Deralaktte mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7892874910 |
| Fax |
|
| Email |
kushishivappa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sripada G Mehandale |
| Designation |
Professor and HOD |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of anaesthesiology and critical care, KS Hegde medical academy, Deralakatte
Mangauru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448384310 |
| Fax |
|
| Email |
sripadamehandale@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kushi TS |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of anaesthesia and ot technology, KS Hegde medical academy, Deralaktte mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7892874910 |
| Fax |
|
| Email |
kushishivappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Deralakatte, Mangaluru, Karnataka |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte, Mangaluru - 575018 |
| Type of Sponsor |
Private 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 |
| DR Sripada G Mehandale |
Justice K S Hegde Charitable Hospital |
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
9448384310
sripadamehandale@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients
Undergoing General Anaesthesia
Requiring IBP Monitoring |
|
| ExclusionCriteria |
| Details |
Refusal To Consent
Peripheral Vascular Disease
Pre-Operative BP Beyond Normal Range
Hypothermia
Artefacts Affecting BP Monitoring |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Find Out The Systolic Blood Pressure With The Help Of Plethysmography and Compare
Plethysmography Derived Blood pressure With systolic blood pressure Derived From Invasive
Blood Pressure |
Intra Operative Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare Plethysmography Derived Blood Pressure With Systolic Blood Pressure Derived From
Non-invasive Blood Pressure |
Intra-Operative Period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/05/2025 |
| 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="0"
Months="6"
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
|
The initial appearance of the plethysmograph waveform can serve as an early indicator of systolic blood pressure (SBP) when a non-invasive blood pressure (NIBP) cuff is deflated after being inflated beyond the point of detectable pulsatile blood flow in the downstream limb, provided both the pulse oximeter and the NIBP cuff are applied on the same limb. This approach can be helpful for quickly estimating SBP even before it is formally displayed on the monitor. In the operating room, several factors particularly motion artifacts such as shivering, patient movement, or positional changes can affect the accuracy of the final NIBP reading. Therefore, the reappearance of the plethysmograph waveform on the pulse oximeter, when both devices are used on the same limb, can provide a rapid and practical indication of blood pressure, especially in situations requiring prompt clinical response. This study aims to assess the accuracy of measuring systolic BP by correlating it with the NIBP cuff pressure at the moment the plethysmograph waveform reappears on the pulse oximeter. |