Critical Incidents Related to Anesthesia and Intensive Care: A Study in a Tertiary Hospital

Critical Incident Clinical Trial

Official title:

Critical Incidents Related to Anesthesia and Intensive Care: A Prospective Study in a Tertiary Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02681159
• Other study ID #: 272/14a/tk
• Status: Active, not recruiting
• Phase: N/A
• First received: January 28, 2016
• Last updated: April 3, 2016
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: April 2016
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jordan: Jordanian Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Over the forthcoming two years, the investigators will study in details critical incidences that may occur to patients in the perioperative period like; acute hypoxic event, acute major hemorrhage, acute airway obstruction and others that may endanger the life or one of the patient organs and whether the patient survive the acute event or die.

These critical incidences will be collected and all information about it will be known in order to be studied and to know were was the defect and eventually to improve the safety of practice of anesthesia and surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients who undergo anesthesia and surgery

• patients who are exposed to a critical incidence

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Incident

Locations

Country	Name	City	State
Jordan	University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No