| CTRI Number |
CTRI/2010/091/000573 [Registered on: 14/06/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare pressure controlled ventilation with volume controlled ventilation during one lung ventilation during surgery |
|
Scientific Title of Study
|
Comparison of the effect of pressure controlled ventilation with volume controlled ventilation during one lung ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A-53/25.07.2007 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof.Lokesh Kashyap |
| Designation |
|
| Affiliation |
|
| Address |
Professor,Department of Anaesthesiology and Intensive care
5th floor, Teaching block, All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868397821 |
| Fax |
|
| Email |
lokeshkashyap@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof.Lokesh Kashyap |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesiology and Intensive care
5th floor, Teaching block, All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868397821 |
| Fax |
|
| Email |
lokeshkashyap@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lokesh Kashyap |
| Designation |
|
| Affiliation |
|
| Address |
Department of Anaesthesiology and Intensive care
5th floor, Teaching block, All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9868397821 |
| Fax |
|
| Email |
lokeshkashyap@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Nil |
| Address |
|
| Type of Sponsor |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
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.Avneep Aggarwal |
Department Of Anaesthesiology, AIIMS, NEW DELHI |
,-
|
09780988126
avn.aiims@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Intraoperative Thoracic surgery, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
volume controlled ventilaton with positive end expiratory pressure(VCV PEEP) and Pressure controlled ventilaton with positive end expiratory pressure(PCV PEEP) |
VCV PEEP for 20 minutes and PCV PEEP for 20 minutes |
| Comparator Agent |
volume controlled ventilaton with zero end expiratory pressure(VCV ZEEP) |
Maintaining end tidal concentration of 35 - 45 mmHg |
|
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Inclusion Criteria
|
| Age From |
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| Age To |
|
| Gender |
|
| Details |
Adult patients ASA physical status II-III undergoing elective open thoracotomy in lateral position requiring one lung anaesthesia for at least one hour. |
|
| ExclusionCriteria |
| Details |
Patients with history of severe cardiovascular, hepatic or renal disease. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Peak inspiratory pressure (P peak), mean inspiratory pressure (P mean), plateau inspiratory pressure (P plateau), arterial PaO2,were recorded |
(1)During two-lung ventilation using VCV before initiation of OLV (VCV- ZEEP)
(2) During OLV 20 mins after the first randomized ventilation mode
(3) 20 mins after the second ventilation mode
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| PaCO2, pH,arterial blood pressure, and expired TV |
(1)During two-lung ventilation using VCV before initiation of OLV (VCV- ZEEP)
(2) During OLV 20 mins after the first randomized ventilation mode
(3) 20 mins after the second ventilation mode
|
|
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Target Sample Size
|
Total Sample Size="32"
Sample Size from India=""
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
The use of pressure control ventilation with PEEP during one lung ventilation is found to be associated with significantly lower peak airway pressures as compared to volume control ventilation with PEEP. However pressure control ventilation with PEEP did not result in improvement in arterial oxygenation. |