| CTRI Number |
CTRI/2023/12/060695 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
use of ESPA surgical safety checklist in Paediatric surgery operation theatre |
|
Scientific Title of Study
|
Compliance and Adherence to ESPA (European Society of Paediatric Anaesthesiology)surgical safety checklist at a paediatric surgical OT: A Prospective Observational Cross-sectional 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 |
Abdul Rahman S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7904453236 |
| Fax |
|
| Email |
itss.abdul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahna Ali |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University. |
| Address |
Department of Anaesthesiology and Critical care,Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9411979684 |
| Fax |
|
| Email |
drshahna.farhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Rahman S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University. |
| Address |
Department of Anesthesiology and Critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7904453236 |
| Fax |
|
| Email |
itss.abdul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical care Jawaharlal Nehru Medical College AMU |
| Address |
Department of Anesthesiology and Critical care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh. |
| Type of Sponsor |
Government 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 Abdul Rahman S |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
Department of Anesthesiology and Critical care.
Aligarh
UTTAR PRADESH |
7904453236
itss.abdul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Regd) Jawaharlal Nehru Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgery cases both major and
minor Operated under General Anaesthesia as
well Regional Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Emergency surgeries, Cases done under local anaesthesia and Cases where parental consent was
not given. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adherence Rate and completion Rate |
At sign-in, time-out, sign-out phases of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compliance rate, Phase analysis based on score of checklist,Usage association with status of completeness with respect to type of surgery (Major vs
Minor) & type of Anaesthesia (GA & SA). |
During sign-in time-out & sign-out phases of surgery |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
29/12/2023 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [itss.abdul@gmail.com].
- For how long will this data be available start date provided 28-12-2023 and end date provided 28-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Compliance and adherence to ESPA surgical safety checklist at a paediatric surgical OT: A Prospective Observational Cross- sectional study.
One of the international patient safety goals for health care is to ensure safe surgery for all. There is every chance of unwanted disasters in operating room especially in paediatric surgery cases. Paediatric patients in particular look alike, bear similar names and are often unable to communicate their own names and complaints.In order to assure safe surgery settings under all circumstances in 2008. WHO surgical safety checklist was introduced as a result of “safe surgery save lives†campaign and it was revised in 2009. Our study is to assess the compliance and adherence to ESPA surgical safety checklist in paediatric surgery OT at the university teaching hospital. |