NCT02681159

Brief Summary

Critical incidents 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 in this regards are retrospective with many drawbacks and pitfalls like absence of information in the records of the patients. In the investigators' study, the investigators will follow the critical incidents among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018, by examining the patients records from the hospital database and recording the events that occur to the patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

January 28, 2016

Last Update Submit

April 3, 2016

Conditions

Keywords

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • number of anesthetized patients who have perioperative critical incidence.

    Critical incidence will include: Aspiration , Laryngospasm , Hypoxemia, Hypoventilation , Hypertension , Hypotension, Myocardial ischemia / infarction, Cardiac arrhythmia, Acute cardiac decompensation , Dental lesion , Nerve / skin / cornea lesion , Lesion through needle puncture , Hypothermia , Conversion of regional anesthesia / inadequate block, Urinary retention , Inadequate postoperative analgesia , Postoperative agitation ,) Awareness , Allergic reaction, Transfusion / mediation error, Miscellaneous.

    14 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who undergo anesthesia and surgery and be exposed to a critical incidence.

You may qualify if:

  • patients who undergo anesthesia and surgery
  • patients who are exposed to a critical incidence

You may not qualify if:

  • patients who undergo anesthesia and surgery and do not expose to critical incidents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan

Amman, 11942, Jordan

Location

Related Publications (1)

  • Munting KE, van Zaane B, Schouten AN, van Wolfswinkel L, de Graaff JC. Reporting critical incidents in a tertiary hospital: a historical cohort study of 110,310 procedures. Can J Anaesth. 2015 Dec;62(12):1248-58. doi: 10.1007/s12630-015-0492-y. Epub 2015 Sep 25.

    PMID: 26407581BACKGROUND

Study Officials

  • Subhi M Alghanem, FFARCS

    University of Jordan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 12, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

April 5, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations