ARISCAT and LAS VEGUS Risk Scores for Predicting Postoper... | NCT06173583

Studies
ARISCAT and LAS VEGUS Risk Scores for Predicting Postoperative Pulmonary Complications After Cardiac Surgery

NCT06173583

Sponsor

Aga Khan University

Status

Completed

Last Update Posted

Feb 14, 2024Actual

Enrollment

181Actual

Phase

Not provided

Conditions

Pulmonary Complication
Postoperative Complications
Postoperative Pulmonary Complications

Interventions

Detection/screening

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2020Actual

Primary Completion Date

Jan 31, 2021Actual

Completion Date

Jan 31, 2021Actual

First Submitted Date

Dec 8, 2023

First Submission Date that Met QC Criteria

Dec 8, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2024

Last Update Posted Date

Feb 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to compare the, ARISCAT and LAS VEGUS scales, for predicting postoperative pulmonary complications in patients undergoing cardiac surgery. The study aims to compare the diagnostic accuracies of the two risk prediction scores in predicting postoperative pulmonary complications.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

181Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult In-patient Cardiac surgery		Adult patients undergoing elective open-heart surgery	Diagnostic Test: Detection/screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Detection/screening	Diagnostic Test	Using ARISCAT and LAS VEGUS risk scores for predicting PPCs	Adult In-patient Cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic Accuracy of ARISCAT and LAS VEGAS Scoring systems	Diagnostic Accuracy to judge the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) and Local Assessment of Ventilatory Management During General Anaesthesia for Surgery (LAS VEGAS) Scoring systems to predict Postoperative Pulmonary Complications (PPC) after Cardiac surgery. Scores, ARISCAT ≥ 27 and LAS VEGAS ≥ 8 were determined for PPCs.	Day 1-5

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing elective heart surgery

Exclusion Criteria:

Refusal to consent
Patients undergoing emergency surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients of either gender, aged between 18-65 years, undergoing elective heart surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aga Khan University Hospital		Karachi	Sindh	74800	Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008403	Mass Screening

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006306	Health Surveys
D011795	Surveys and Questionnaires

Browse Leaves

Not provided

Browse Branches

Not provided