| CTRI Number |
CTRI/2024/11/076960 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing changes in hemodynamics and respiratory parameters in different modes of ventilation in patients undergoing spine surgeries in prone position. |
|
Scientific Title of Study
|
The comparative study of effects of volume controlled ventilation (VCV) and pressure controlled ventilation (PCV) on hemodynamics and respiratory mechanics in patients undergoing spine surgeries in prone position-prospective randomised controlled 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 |
DrAshwini H |
| Designation |
Professor MD.Anaesthesiology |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Rajarajeswari medical college and hospital kengeri satellite town kambipura
Bangalore KARNATAKA 560074 India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih29@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrAshwini H |
| Designation |
Professor MD.Anaesthesiology |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Rajarajeswari medical college and hospital kengeri satellite town kambipura
Bangalore KARNATAKA 560074 India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih29@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrAshwini H |
| Designation |
Professor MD.Anaesthesiology |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Rajarajeswari medical college and hospital kengeri satellite town kambipura
Bangalore KARNATAKA 560074 India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, 2nd floor , rajarajeswari medical college and hospital , bangalore-560074 |
|
|
Primary Sponsor
|
| Name |
Jasni KB |
| Address |
Rajarajeswari medical college and hospital, mysore road, kambipura, bangalore, karnataka-560074 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrJasni KB |
Rajarajeswari medical college and hospital |
Department of Anaesthesiology, Rajarajeswari medical college and hospital , mysore road, kambipura, bangalore, karnataka - 560074 Bangalore KARNATAKA |
9538808087
jasnibasheer97@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PRESSURE CONTROLLED VENTILATION (PCV) |
All patients will be ventilated with Anesthesia workstation (Drager Atlan A350)P peak in PCV will be adjusted to deliver Vt of 8 ml/kg ideal body weight and Respiratory Rate [RR] will be adjusted to keep end tidal carbon oxide (EtCO2) between 33–36 mm Hg.
It will have standardised ventilatory settings with Fractional inspired oxygen concentration (FiO2) of 0.4, Positive End Expiratory Pressure (PEEP) of 5 cm H2O and Inspiratory: Expiratory time (I:E) of 1:2 ratio. Duration as per surgical requirements |
| Comparator Agent |
VOLUME CONTROL VENTILATION (VCV) |
All patients will be ventilated with Anesthesia workstation ,tidal volume (Vt) in VCV will be adjusted to deliver Vt of 8 ml/kg ideal body weight and Respiratory Rate [RR] will be adjusted to keep end tidal carbon oxide (EtCO2) between 33–36 mm Hg. It will have standardised ventilatory settings with Fractional inspired oxygen concentration (FiO2) of 0.4, Positive End Expiratory Pressure (PEEP) of 5 cm H2O and Inspiratory: Expiratory time (I:E) of 1:2 ratio. Duration as per surgical requirements |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA-1 and ASA-2 patients aged 20-60 years scheduled for elective spine surgeries in prone position under general anaesthesia will be enrolled for the study. |
|
| ExclusionCriteria |
| Details |
Body mass index (BMI) >30
Documented autonomic neuropathy
Obstructive or restrictive lung diseases
Repeat spine surgeries
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of PCV with VCV on lung mechanics, oxygenation, ventilation and intra-operative bleeding. |
To compare the effects of respiratory mechanics after intubation under supine position, after proning, then at 20 minutes , 30 minutes, 60 minutes, 90 minutes, 120 mins , 150 minutes, 180 minutes, till the end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of these two modes of ventilation on hemodynamics. |
To study the hemodynamic changes
I.e baseline & every 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/01/2025 |
| 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="1" 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
|
Volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) are two traditional ventilation modes in operating room, with different respiratory mechanics. The two ventilation modes have different influences on intrathoracic pressure and consequently venous return.During general anaesthesia, changing from supine to prone position may have adverse effects on oxygenation, ventilation and circulation. Prone position interferes with lung mechanics by decreasing the pulmonary compliance and increasing the airway pressure1-3. High airway pressure may in turn impair venous return to heart, decrease cardiac output and increase the systemic venous pressure. Different modes of mechanical ventilation are used to balance respiratory mechanics, gas exchange and hemodynamics. Volume-controlled ventilation (VCV) has been widely used as a positive-pressure ventilation (PPV) method during anesthesia, but this method does increase airway pressure when chest compliance is decreased as occurs in during prone position surgeries. This increased airway pressure will be reflected as increased epidural venous pressure leading to increased surgical bleeding. On the other hand, pressure-controlled ventilation (PCV) limits the peak airway pressure (Ppeak) and reduces intrathoracic pressure thereby improving venous return and cardiac output.4 However, advantage of PCV over VCV in improvement of oxygenation and ventilation has shown inconsistent results. To surgeons, the major problems encountered performing spine surgery are those of exposure and bleeding. To anaesthesiologists, the major problems noted in those patients are difficulties with ventilation and with cardiac dysfunction if the abdomen and chest are restricted.5 The present study aims to compare the effects of PCV with VCV on lung mechanics, oxygenation, ventilation and hemodynamics. |