Comparison of On-hours Versus Off-hours Anesthesia of Hip... | NCT04957121

Studies
Comparison of On-hours Versus Off-hours Anesthesia of Hip Surgery

NCT04957121

Sponsor

Huazhong University of Science and Technology

Status

Completed

Last Update Posted

Aug 23, 2021Actual

Enrollment

1,843Actual

Phase

Not provided

Conditions

Off-hours Anesthesia

Interventions

on-hours
off-hours

Countries

China

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

Aug 2021

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

Jul 2, 2021Actual

Primary Completion Date

Aug 8, 2021Actual

Completion Date

Aug 20, 2021Actual

First Submitted Date

Jun 21, 2021

First Submission Date that Met QC Criteria

Jun 30, 2021

First Posted Date

Jul 12, 2021Actual

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

Aug 20, 2021

Last Update Posted Date

Aug 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Mei, Deputy Director of Anesthesiology Department of Tongji Hospital Affiliated to Huazhong University of Science and Technology, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

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

To explore the impact of the begin time of anesthesia on in-hospital mortality and early prognosis of patients undergoing hip surgery.

Detailed Description

The patients undergoing hip surgery between were divided into the on-hours group or the off-hours group depending on the begin time of anesthesia in this retrospective cohort study. In-hospital mortality and early prognosis were compared between the two groups.

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

1,843Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
on-hours		Hip surgeries with the start time of anesthesia between 8:00 and 17:59 were coded as "on-hours".	Other: on-hours
off-hours		Hip surgeries with anesthesia beginning between 18:00 and 7:59 were coded as "off-hours". Besides, taking the long duration of hip surgery into account, if the anesthesia began before 18:00 but ended after 20:00, it was also defined as "off-hours".	Other: off-hours

Interventions

Name	Type	Description	Arm Group Labels	Other Names
on-hours	Other	If the begin time of anesthesia was between 8:00 to 17:59, it was defined as "on-hours".	on-hours

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
in-hospital mortality	the mortality during hospitalization	up to 7 months

Secondary Outcomes

Measure	Description	Time Frame
postoperative LOS	postoperative hospital length of stay	up to 4 months postoperatively
total LOS	total hospital length of stay	up to 7 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who had hip surgery between January 1, 2015, and December 31, 2020 in Tongji Hospital.

Exclusion Criteria:

under 18 years old
had incomplete perioperative data

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

Patients who had hip surgery during on-hours or off-hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei Mei	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided