Death Rate in Anesthesia: A Study in a Tertiary Hospital | NCT02685540

Studies
Death Rate in Anesthesia: A Study in a Tertiary Hospital

NCT02685540

Sponsor

University of Jordan

Status

Unknown status

Last Update Posted

Apr 5, 2016Estimated

Enrollment

792Estimated

Phase

Not provided

Conditions

Sudden Death

Interventions

Not provided

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

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 14, 2016

First Submission Date that Met QC Criteria

Feb 17, 2016

First Posted Date

Feb 18, 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

Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients.

In the investigators study, the investigator will review the death rate in anesthesia whether regional or general over the past five years from 2010 to 2014, by examining the patients records from the hospital database.

Detailed Description

Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients. Most of the studies of death rate in anesthesia are retrospective. Although retrospective studies suffer many draw backs in their design and results, but they are still common method to evaluate the safety of anesthesia practice for surgical patients.

In the investigators study, the investigators will review the death rate in anesthesia whether regional or general over the past five years from 2010 to 2014, by examining the patients records from the hospital database.

The cause of death will be grouped into: totally anesthesia related, partially anesthesia related, surgery related or patient condition related.

The records and files of dead patients will be examined by committee from the researchers to estimate the cause of death.

The end point of the investigators study will be anesthesia death rate inside the hospital.

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

792Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of anesthetized patients who died in the perioperative period inside the hospital		30 days post-operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent anesthesia and surgery.
Patients who died inside the hospital.

Exclusion Criteria:

Patient who underwent anesthesia and surgery and do not died and discharged home.
Patients who died outside the hospital.

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 underwent anesthesia and surgery and died inside the hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Subhi M Alghanem, FFARCS	Contact	00962795640592		alghanem@ju.edu.jo

Overall Officials

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

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24841805	Background	Watters DA, Hollands MJ, Gruen RL, Maoate K, Perndt H, McDougall RJ, Morriss WW, Tangi V, Casey KM, McQueen KA. Perioperative mortality rate (POMR): a global indicator of access to safe surgery and anaesthesia. World J Surg. 2015 Apr;39(4):856-64. doi: 10.1007/s00268-014-2638-4.

ID	Term
D003643	Death
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms