CTRI

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CTRI Number

CTRI/2024/06/068341 [Registered on: 05/06/2024] Trial Registered Prospectively

Last Modified On:

03/06/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Other

Public Title of Study

Developing predictive models using machine learning techniques to assess the risk factors influencing post operative Peak expiratory flow rate following upper abdominal surgery.

Scientific Title of Study

Developing machine learning predictive models for personalized PEFR risk assessment in upper abdominal surgery patients: An 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 Lairenjam Deepa Devi
Designation	Post Graduate in Department of Anaesthesiology
Affiliation	Rajarajeswari Medical college and hospital
Address	Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore Karnataka 560074, India Bangalore KARNATAKA 560074 India
Phone	06239217231
Fax
Email	chaolai91@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sowmya Jois
Designation	Associate Professor
Affiliation	Rajarajeswari Medical College and Hospital
Address	Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore, Karnataka 560074,India Bangalore KARNATAKA 560074 India
Phone	09980891082
Fax
Email	Drsowmyasharma@gmail.com

Details of Contact Person
Public Query

Name	Dr Sowmya Jois
Designation	Associate Professor
Affiliation	Rajarajeswari Medical College and Hospital
Address	Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore, Karnataka 560074,India Bangalore KARNATAKA 560074 India
Phone	09980891082
Fax
Email	Drsowmyasharma@gmail.com

Source of Monetary or Material Support

Department of Anaesthesiology, 2nd floor, Rajarajeswari Medical college and hospital , Bangalore -560074

Primary Sponsor

Name	Dr Lairenjam Deepa Devi
Address	Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore Karnataka 560074, India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Lairenjam Deepa Devi	Rajarajeswari Medical College and Hospital	Department Of Anaesthesiology Rajarajeswari Medical College And Hospital, Mysore Road, Kambipura, Bangalore Karnataka 560074, India Bangalore KARNATAKA	06239217231 chaolai91@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics committe	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Patients scheduled for elective upper abdominal surgeries e.g. cholecystectomy, gastrectomy, hernia repair either open or laparoscopic. 2. Adults aged 18years and above.

ExclusionCriteria

Details

1. Emergency surgeries.
2. Patients unable to provide informed consent.
3. Patients who are unable to comprehend and perform PEFR

Method of Generating Random Sequence

Other

Method of Concealment

An Open list of random numbers

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
To assess various preoperative, intraoperative and postoperative factors that can cause reduction in postoperative PEFR.	Baseline 6th hour postoperative 24th hour postoperative 48th hour postoperative

Secondary Outcome

Outcome

TimePoints

To develop predictive models using machine learning algorithms for assessment of risk factors of patients undergoing upper abdominal surgeries based on preoperative characteristics, surgical factors. and Anesthesia protocols to identify individuals at high risk reduction of PEFR.
To validate the predictive models and assess their accuracy in identifying patients at risk of reduced PEFR postoperative.

6th hour
24th hour
48th hour

Target Sample Size

Total Sample Size="62"
Sample Size from India="62"
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)

14/06/2024

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 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

62 patients scheduled for upper abdominal surgeries will be screened for inclusion and exclusion criteria and informed consent will be taken. The study involves collection of data on preoperative patient characteristics, surgical factors, anesthesia protocols and relevant parameters. Preoperative baseline data including demographic information, comorbidities and preoperative PFT will be recorded. Intraoperative data such as surgical details, anesthetic agents used, and duration of surgery will be documented. After surgery, postoperative PEFR will be done 6th hours, 24th hours & 48th hours. If the patients received truncal blocks in addition to general anesthesia will be noted.