| CTRI Number |
CTRI/2019/07/020316 [Registered on: 22/07/2019] Trial Registered Prospectively |
| Last Modified On: |
21/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
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Cohort Study |
| Study Design |
Other |
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Public Title of Study
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A study to compare the procedure of giving small bolus of fluid through vein during surgery on paralyzed patients, ventilated by machine, lying on abdomen for its effect on changes in fluid requirement in two groups, one with disturbed autonomic nervous system and another with intact system. |
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Scientific Title of Study
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A Study to Compare intraoperative fluid responsiveness in patients mechanically ventilated in prone position with and without pre-existing autonomic dysfunction – A prospective controlled observational study. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR FAHMEENA BEGUM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
NIZAMS INTITUTE OF MEDICAL SCIENCES, HYDERABAD |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE,
NIZAMS INSTITUTE OF MEDICAL SCIENCES,PUNJAGUTTA,
HYDERABAD
Hyderabad
TELANGANA
500082
India |
| Phone |
9573633765 |
| Fax |
|
| Email |
fahmeena27@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
DR ABHIRUCHI YESHWANT PATKI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NIZAMS INTITUTE OF MEDICAL SCIENCES, HYDERABAD |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE,
NIZAMS INSTITUTE OF MEDICAL SCIENCES,PUNJAGUTTA,
HYDERABAD
Hyderabad
TELANGANA
500082
India |
| Phone |
|
| Fax |
|
| Email |
abhiruchipatki2204@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR FAHMEENA BEGUM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
NIZAMS INTITUTE OF MEDICAL SCIENCES, HYDERABAD |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE,
NIZAMS INSTITUTE OF MEDICAL SCIENCES,PUNJAGUTTA,
HYDERABAD
Hyderabad
TELANGANA
500082
India |
| Phone |
9573633765 |
| Fax |
|
| Email |
fahmeena27@gmail.com |
|
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Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE,
NIZAMS INTITUTE OF MEDICAL SCIENCES,
HYDERABAD |
|
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Primary Sponsor
|
| Name |
DR FAHMEENA BEGUM |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE,
NIZAMS INTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA,
HYDERABAD,
TELANGANA-500082 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR FAHMEENA BEGUM |
NIZAMS INSTITUTE OF MEDICAL SCIENCES, HYDERABAD |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE,
NIZAMS INSTITUTE OF MEDICAL SCIENCES, PUNJAGUTTA,
HYDERABAD-500082
Hyderabad
TELANGANA |
9573633765
fahmeena27@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INTITUTIONAL ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 to 60 years.
2. Either sex
3. ASA I and II
4. Scheduled for prone position surgery |
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate.
2. Patients who are unable to perform bed side autonomic dysfunction tests.
3. Patients with abnormal renal function tests and hepatic function tests.
4. Patients with raised baseline and intraoperative blood pressures.
5. Those patients who needed vasoactive drugs during surgery to maintain hemodynamic stability.
6. Patients with Cardiac or Respiratory compromise.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare intraoperative fluid responsiveness (SPV changes) in mechanically ventilated patients in prone position with and without autonomic dysfunction. |
During the surgery |
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Secondary Outcome
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| Outcome |
TimePoints |
| To compare changes in Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP) in mechanically ventilated patients in prone position with and without autonomic dysfunction. |
During the surgery |
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Target Sample Size
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Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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A Prospective single blinded controlled Observational study will be conducted in 60 patients electively posted for surgery in prone position. Patients will be recruited and divided into 2 groups of 30 each based on the results of bedside clinical tests for autonomic dysfunction which will be performed a day before the surgery while doing the pre-anaesthetic check up.
Group 1 : Patients with autonomic dysfunction.
Group 2 : Patients without autonomic dysfunction.
Intra-operatively these patients will be subjected to a fluid bolus of 6% Hydroxyethyl starch and SPV changes (Systolic pressure variation -- dynamic index for fluid therapy) will be monitored along with continuous monitoring of Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) and ECG.
The study focuses on comparison of SPV changes in response to intravenous fluid bolus between patients with autonomic dysfunction and patients without autonomic dysfunction.
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