The Safety of Anesthesia Management for Traumatic Hip Sur... | NCT02692989

Studies
The Safety of Anesthesia Management for Traumatic Hip Surgery in Elderly

NCT02692989

Sponsor

University of Jordan

Status

Unknown status

Last Update Posted

Apr 5, 2016Estimated

Enrollment

1,270Actual

Phase

Not provided

Conditions

Hip Fractures

Interventions

Hip fracture surgery and anesthesia

Countries

Jordan

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jul 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Feb 23, 2016

First Submission Date that Met QC Criteria

Feb 25, 2016

First Posted Date

Feb 26, 2016Estimated

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

Apr 3, 2016

Last Update Posted Date

Apr 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Subhi M. Alghanem, Professor of Anesthesia and Intensive Care, University of JordanPrincipal Investigator

Lead Sponsor

University of JordanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Trauma for hip joint is common in old people. Anesthesia in these types of old patients carries more risk than the adult population.

In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications.

Detailed Description

Trauma for hip joint is common in old people; usually trauma for the hip joint is treated surgically under anesthesia. Anesthesia in these types of old patients carries more risk than the adult population, since these type of patients have a lot of chronic diseases which affect their general health.

In this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia between the years 2010 to 2015, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications like Deep Venous Thrombosis, Pulmonary complications, myocardial Infarction and others.

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

1,270Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hip fracture surgery and anesthesia	Procedure	any operative fixation for hip fracture whether under General Anesthesia or Regional anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications	Complications like: Deep Venous Thrombosis, Pulmonary complications, Myocardial Infarction and others.	30 days post-operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who sustained hip fracture.
patients who underwent surgical correction under Regional or general anesthesia.

Exclusion Criteria:

Patients who sustained Hip fractures but treated conservatively.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients who sustained hip fracture and underwent surgical correction under Regional or general anesthesia and had intraoperative or postoperative complications

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Subhi M Alghanem, FFARCS	Jordan University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Jordan		Amman		11942	Jordan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10823094	Background	Urwin SC, Parker MJ, Griffiths R. General versus regional anaesthesia for hip fracture surgery: a meta-analysis of randomized trials. Br J Anaesth. 2000 Apr;84(4):450-5. doi: 10.1093/oxfordjournals.bja.a013468.

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries