Critical IncidentNCT02681159
Critical Incidents Related to Anesthesia and Intensive Care: A Study in a Tertiary Hospital
An observational study of Critical Incident, run by University of Jordan at 1 site in Jordan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Incident
- How many people
- 150 participants
- Where
- 1 siteJordan
- Study dates
- Jan 2016to Jun 2018
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who undergo anesthesia and surgery and be exposed to a critical incidence.
Who may be able to join
- patients who undergo anesthesia and surgery
- patients who are exposed to a critical incidence
Who cannot join
- patients who undergo anesthesia and surgery and do not expose to critical incidents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Critical Incidents Related to Anesthesia and Intensive Care: A Prospective Study in a Tertiary Hospital
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.
Read the detailed 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.
- Conditions
- Critical Incident
- Keywords
- Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IncidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhi M. Alghanem, University of Jordan
- Investigators
- Subhi M Alghanem, FFARCS, Study chair, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681159
- Sponsor's protocol ID
- 272/14a/tk
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26407581
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Incidents Related to Anesthesia and Intensive Care: A Prospective Study in a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT02681159
- Acronym / sponsor ID
- 272/14a/tk
- Conditions
- Critical Incident
- Keywords
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who undergo anesthesia and surgery and be exposed to a critical incidence.
Key inclusion criteria (2 listed)
- patients who undergo anesthesia and surgery
- patients who are exposed to a critical incidence
Key exclusion criteria (1 listed)
- patients who undergo anesthesia and surgery and do not expose to critical incidents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of anesthetized patients who have perioperative critical incidence.
Time frame: 14 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Background: PubMed 26407581Munting 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhi M Alghanem, FFARCS study chair
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Incident, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of anesthetized patients who have perioperative critical incidence. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.