| CTRI Number |
CTRI/2023/02/049681 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
comparing sound levels in the operation theatre during emergency and elective caesarean delivery |
|
Scientific Title of Study
|
Comparing noise levels in elective and emergency caesarean deliveries - A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lavanya Kaparti |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department of Anaesthesiology, SDUMC, Tamaka, Kolar 563103
Kolar
KARNATAKA
563101
India |
| Phone |
9845203715 |
| Fax |
|
| Email |
drlavanyakaparti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lavanya Kaparti |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department of Anaesthesiology, SDUMC, Tamaka, Kolar 563103
Kolar
KARNATAKA
563101
India |
| Phone |
9845203715 |
| Fax |
|
| Email |
drlavanyakaparti@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Lavanya Kaparti |
| Designation |
Associate Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department of Anaesthesiology, SDUMC, Tamaka, Kolar 563103
Kolar
KARNATAKA
563101
India |
| Phone |
9845203715 |
| Fax |
|
| Email |
drlavanyakaparti@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College, Tamaka, Kolar |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Medical College |
| Address |
Department of Anaesthesiology
Tamaka, Kolar 563103 |
| 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 Lavanya Kaparti |
SDUMC |
Obstetric OT Complex, critical care building, SDUMC, Tamaka, Kolar 563103
Kolar
KARNATAKA |
9845203715
drlavanyakaparti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA 2 patients coming for Caesarean Delivery |
|
| ExclusionCriteria |
| Details |
ASA 3 and above patients
patients undergoing Caesarean delivery under GA |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| noise levels at different time points during caesarean section |
T 1 when the anaethesiologist enters OT
T 2 Just before time out
T 3 Neuraxial block placement
T 4 Skin Incision
T 5 Baby extraction
T 6 End of skin closure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure sound levels at different time points during caesarean delivery |
T1 - when anaesthesia provider enters OT
T2 at Timeout
T3 during neuraxial block administration |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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)
|
15/02/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Excessive noise has negative implications for both clinicians and patients. Operating rooms are particularly noisy due to background noises from air handlers, forced air warmers etc. emergency Caesarean deliveries require rapid co ordination and communication. high noise levels can impede verbal communication which is critical in such surgeries. We plan to conduct a study in Obstetric OT to measure noise levels and to compare noise levels during elective and emergency caesarean deliveries. |