| CTRI Number |
CTRI/2025/07/091714 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Prone Positioning on Respiratory Mechanics in Anaesthetized Patients with and without Bolsters |
|
Scientific Title of Study
|
The effect of prone position on the respiratory mechanics, with and without bolsters in patients under general anaesthesia : A cross sectional 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 |
Dr Mahesh Chandra |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeswari Medical College And Hospital Bangalore |
| Address |
No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India.
Bangalore KARNATAKA 560074 India |
| Phone |
9483251081 |
| Fax |
|
| Email |
Mahesh324@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr G K ANKUSH |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Medical College And Hospital Bangalore |
| Address |
No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India.
Bangalore KARNATAKA 560074 India |
| Phone |
7338120305 |
| Fax |
|
| Email |
28121998gkankush@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr G K ANKUSH |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Medical College And Hospital Bangalore |
| Address |
No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India.
Bangalore KARNATAKA 560074 India |
| Phone |
7338120305 |
| Fax |
|
| Email |
28121998gkankush@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajarajeswari Medical College And Hospital , Bangalore |
| Address |
No 202, 2nd Floor, Department of Anaesthesiology, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India. |
| 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 Mahesh Chandra |
RajaRajeswari Medical College And Hospital , Bangalore |
Department of Anaesthesiology,2nd Floor, RajaRajeswari Medical College and Hospital, Kambipura, Mysore Road, Bangalore - 560074, Karnataka, India. Bangalore KARNATAKA |
9483251081
Mahesh324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RRMCH Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder, (2) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age group 20 to 60 years, undergoing elective surgeries under general anaesthesia in the prone position.
2) Patients classified under American Society of Anaesthesiologists (ASA) 1 and 2 after thorough Pre-Anaesthetic evaluation.
|
|
| ExclusionCriteria |
| Details |
1)Patient refusal.
2)Pregnant women.
3)Patients with BMI of 30kg/m2 and more.
4)Patients undergoing emergency surgeries.
5)Patients with significant spinal deformities, scoliosis, lardosis, kyphosis, ankylosing spondylitis.
6)Post intubation Bronchospasm.
7)Patients with compromised Respiratory conditions.
8)Patients with Oropharyngeal or Facial Pathologies
9)Patients who are active smokers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dynamic compliance of the respiratory system |
5 minutes after intubation, Prone, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, After making supine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak airway pressure (P peak), mean airway pressure (P mean), end tidal CO2(EtCO2), heart rate (HR), mean arterial pressure (MAP) and oxygen saturation (SpO2) |
5 minutes after intubation, Prone, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, After making supine |
|
|
Target Sample Size
|
Total Sample Size="106" Sample Size from India="106"
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)
|
08/08/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
When
a patient is positioned in the prone posture under general anaesthesia,
abdominal pressure exerts force on the internal organs, causing the diaphragm
to shift towards the cephalad direction. Additionally, the weight of the trunk
compresses the thoracic cavity, reducing the anterior-posterior chest diameter. These alterations in body
mechanics lead to a 20-30 percent reduction in respiratory compliance and an
increase in peak inspiratory pressure. Consequently, the observed rise in PIP
during prone positioning is primarily attributed to the diminished respiratory
compliance resulting from these mechanical factors.
In
conditions of reduced pulmonary compliance, achieving adequate ventilation may
necessitate the use of elevated airway pressures. These elevated pressures can
compromise venous return to the heart, leading to a reduction in cardiac output
and an elevation in systemic venous pressure. Increased venous pressure in the
epidural venous plexus is a recognized contributor to excessive surgical
bleeding. Furthermore, elevated spinal venous pressure can decrease spinal cord
perfusion pressure, calculated as the difference between mean arterial pressure
and spinal venous pressure, thereby increasing the risk of neurological
complications.
To
mitigate these variations, a bolster is traditionally placed beneath the chest
and pelvis to reduce intra-abdominal pressure and its associated physiological
alterations. Spine surgeons commonly employ these bolsters to achieve optimal
patient positioning during spinal surgeries. However, in percutaneous
nephrolithotomy procedures, urologists typically avoid the use of such
supports, as they can obstruct surgical access to the targeted area
Thus, this study will compare the changes in Dynamic
compliance of the respiratory system in the prone position with and without
bolsters. In addition, changes in Peak airway pressure, mean airway pressure,
EtCO2, heart rate, mean arterial pressure and Oxygen saturation will also be studied. |