| CTRI Number |
CTRI/2017/11/010641 [Registered on: 24/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparisson of blood pressure measured from Noninvasive/Automated (NIBP} technique and Manual technique (Sphygmomanometer) with direct invasive blood pressure (Arterial Line) measurement technique in patient undergoing neurosurgery. |
|
Scientific Title of Study
|
A Comparative Study Of Three Blood Pressure Measuring Techniques In Neurosurgical Patients Undergoing Intraoperative Blood Pressure Manipulation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohit Katare |
| Designation |
Junior Resident (MD Anaesthesiology) |
| Affiliation |
LTMMC/LTGMH Sion Hospital Mumbai |
| Address |
Department of Anaesthesiology LTMMC/LTGMH Sion Hospital Mumbai, Maharashtra
69/5 Pardesipura Indore (M.P)
Pin, 452001
Mumbai
MAHARASHTRA
400022
India |
| Phone |
917506588096 |
| Fax |
|
| Email |
mohitkatarerun4lyf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemangi S Karnik |
| Designation |
Professor Of Anaesthesiology |
| Affiliation |
LTMMC/LTGMH Sion Hospital Mumbai |
| Address |
Department of Anaesthesiology LTMMC/LTGMH Sion Hospital Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
919324501900 |
| Fax |
|
| Email |
dr_hemangi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Katare |
| Designation |
Junior Resident (MD Anaesthesiology) |
| Affiliation |
LTMMC/LTGMH Sion Hospital Mumbai |
| Address |
Department of Anaesthesiology LTMMC/LTGMH Sion Hospital Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400022
India |
| Phone |
917506588096 |
| Fax |
|
| Email |
mohitkatarerun4lyf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Mohit Katare, New RMO Hostel department of anaesthesiology LTMMC & GH Sion, Mumbai |
|
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Primary Sponsor
|
| Name |
Dr Mohit Katare |
| Address |
69/5 Pardesipura Indore M.P |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemangi Karnik |
LTMMC &GH Sion, Mumbai |
Neurosurgical operation theatre, third floor hospital building, Dr. Babasaheb Ambedkar Road, Sion ( west)
Mumbai
MAHARASHTRA |
9167017002
dr_hemangi@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LTMM College & LTMG Hospital Staff and Research Society,Sion ,Mumbai |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neurosurgical patients come for Aneurysm and Arterio-venous malformation Surgery, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard mercury sphygmomanometer, GE healthcare GE DINAMAP oscillometric non-invasive blood pressure technology and Invasive blood pressure monitoring with 20G Jelco cannula with IPEX blood pressure transducer connected to GE Carescape B450 Monitor.
,
|
Mercury sphygmomanometer measures from left arm, Oscillometric from Right arm and readings are compared with continues direct invasive arterial line measurement. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients Undergoing Neurosurgical Procedures requiring blood pressure manipulations under anaesthesia.
patients subjected to radial artery cannulation |
|
| ExclusionCriteria |
| Details |
1. Severely hemodynamic compromised patients.
2. Patients with Arrhythmias.
3. Patents in which there is inability to take Radial Artery Cannulation.
4. Any Contraindications to Cuff application or inflation.
5. Pregnant Females.
6. Difference of more than 10 mm of hg blood pressure in both the arms
7. Different surgical positions other than supine
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non invasive blood pressure monitoring is not reliable alternative to invasive arterial blood pressure monitoring during intraoperative blood pressure manipulation. |
Outcome will be assessed after collection of data from all the 40 patients within period of 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Non invasive blood pressure measuring technique tend to underestimate hypotension and overestimate hypertension |
Outcome will be assessed after collection of data from all the 40 samples within 18 month period. |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/07/2016 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
|
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Brief Summary
|
This is prospective observational study in patients undergoing neurosurgical procedure requiring intraoperative blood pressure manipulation between 2014 and 2016 in neurosurgery operation theatre of LTGM Hospital and Medical college, Sion, Mumbai. During study we compared readings of three blood pressure measuring technique namely Invasive direct arterial blood pressure , non invasive oscillometric blood pressure and auscultatory manual blood pressure at different ranges of blood pressures during intraoperative blood pressure manipulation and establish correlation between these techniques with reliability and accuracy of non invasive blood pressure measuring techniques (oscillometric and auscultatory) considering invasive arterial line as gold standard for blood pressure measurement. We find that both the. Non invasive blood pressure measurement techniques tend to systolic blood pressure measurement, the difference was -9 to +21 mm Hg for oscillometric technique and -10 to + 20 mm Hg by auscultatory technique. Systolic blood pressure at range of 100 to 140 mm Hg both the non invasive techniques are found to be reliable. While at blood pressure above 140 mm Hg both non invasive techniques tend to underestimate systolic pressure reading in which oscillometric by 9 +/- 1.9 mm Hg and auscultatory by 8.58 +/- 0.36 mm Hg which is found to be statistically significant, when we further analyses blood pressure readings below 90 mm Hg. Oscillometric but not auscultatory tended to overestimated systolic pressure reading by 5.7 +/- 3.17 mm Hg. On analysing diastolic blood pressure both the non-invasive techniques tended to overestimate diastolic pressure, oscillometric by 6.42 +/- 7.60 mm Hg and auscultatory by 6.54 +/- 7.52 mm Hg. Mean blood pressure readings were found to be reliable with non-invasive technique.
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