Fast-Track in Cardiac Anesthesia | NCT05321173

Studies
Fast-Track in Cardiac Anesthesia

NCT05321173

Sponsor

Ankara City Hospital Bilkent

Status

Completed

Last Update Posted

May 24, 2022Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Cardiac Surgery

Interventions

Not provided

Countries

Turkey (Türkiye)

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

May 2022

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

Apr 1, 2022Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

May 15, 2022Actual

First Submitted Date

Mar 23, 2022

First Submission Date that Met QC Criteria

Apr 1, 2022

First Posted Date

Apr 11, 2022Actual

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

May 21, 2022

Last Update Posted Date

May 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eda Balcı, Medical Doctor, Ankara City Hospital BilkentPrincipal Investigator

Lead Sponsor

Ankara City Hospital BilkentOTHER

Collaborators

Not provided

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 introduction of fast-track extubation procedures following cardiac surgery has significantly shortened hospitalization times in intensive care units. In this study, it was aimed to determine the obstacles to the early recovery of patients who underwent cardiac surgery in the crisis environment that developed with the pandemic.

Detailed Description

After the time we struggled to overcome the many crises that the pandemic period brought to our lives, it has been clearly seen that the decrease in the number of nurses and doctors and the limitation of the number of beds allocated for postoperative intensive care have been mandatory attempts due to the shift of personnel to areas to fight the pandemic. The fact that cardiac surgery operations are not elective and cardiac patients cannot wait for a long time due to their existing pathologies has led physicians to strive to provide the best service with available resources. To ensure that the cardiac surgery operating room and intensive care beds of our hospital can be used more efficiently and to take initiatives to optimize the recovery in the postoperative period are among the important goals of today and the future. The reason for this is not only to reduce costs and loss of workforce but also to be ready for any crisis time. In addition, it is aimed to perform the operations of critical patients without delay and to successfully discharge them. In the postoperative period, if the functions of many basic organ systems can provide the necessary ideal conditions, the patients can be extubated within 8 hours in fast-track cardiac anesthesia (FTCA) programs. Some problems persist or occur in patients with functional problems such as hemodynamics, cardiac, and respiration who do not meet the extubation criteria. For all these reasons, a prospective, cross-sectional study was planned to focus on daily standard practices and improve areas of failure.

Accordingly, this study aimed to examine the preoperative, intraoperative, and postoperative characteristics of patients who underwent cardiac surgery, and to investigate the factors in patients who could not be extubated within 8 hours after surgery.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extubation ≤ 8 hour		Patients who mechanically ventilated less than 8 hours postoperatively
Extubation > 8 hour		Patients who mechanically ventilated more than 8 hours postoperatively

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extubation time	Mechanical ventilation duration postoperatively	Postoperative period, up to 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients who underwent elective or emergency cardiac surgery

Exclusion Criteria:

Patients undergoing pediatric cardiac surgeries

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients who underwent elective or emergency cardiac surgery within 2 months

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ZELİHA A DEMİR, Professor	Ankara City Hospital Bilkent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara City Hospital		Ankara	Select State/Province	06800	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22951954	Result	Haanschoten MC, van Straten AH, ter Woorst JF, Stepaniak PS, van der Meer AD, van Zundert AA, Soliman Hamad MA. Fast-track practice in cardiac surgery: results and predictors of outcome. Interact Cardiovasc Thorac Surg. 2012 Dec;15(6):989-94. doi: 10.1093/icvts/ivs393. Epub 2012 Sep 5.
27616189	Result	Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.