Sudden DeathNCT02732067
Death Rate in Anesthesia, a Study in a Tertiary Hospital
An observational study of Sudden Death, run by University of Jordan at 1 site in Jordan.
Trial 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 this study, the investigators will follow the death among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Death
- What is being tested?
- anesthesia related deaths
- How many people
- 30 participants
- Where
- 1 siteJordan
- Study dates
- Jan 2016to Jun 2018
- 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 underwent anesthesia and surgery and died inside the hospital
Who may be able to join
- Patients who underwent anesthesia and surgery.
- Patients who died inside the hospital.
Who cannot join
- Patient who underwent anesthesia and surgery and do not died and discharged home.
- Patients who died outside the hospital.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
University of Jordan
Amman, 11942
Amira Masri, Professor, 00962 6 5353444, amasri@ju.edu.jo
About this study
Official title: Death Rate in Anesthesia: a Prospective Study of Two Years Period From a Tertiary Hospital
Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients.
In this study, the investigators will follow the death among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018.
Read the 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 with many drawbacks and pitfalls like absence of information in the records of the patients.
In this study, the investigators will follow the death 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 dead patients.
The end point of this study will be anesthesia death rate inside the hospital.
- Conditions
- Sudden Death
- Being tested
- anesthesia related deaths
- Keywords
- Anesthesia
- Medical subject headings
- Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia related deathsOther
number of anesthetized patients who died in the perioperative period inside the hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
number of anesthetized patients who died in the perioperative period inside the hospital
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 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 Sudden DeathStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
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, Jordan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732067
- Sponsor's protocol ID
- 270/14a/tk
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24841805
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Death Rate in Anesthesia: a Prospective Study of Two Years Period From a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT02732067
- Acronym / sponsor ID
- 270/14a/tk
- Conditions
- Sudden Death
- Keywords
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 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
- 8 Apr 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.
Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients.
In this study, the investigators will follow the death among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018.
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 with many drawbacks and pitfalls like absence of information in the records of the patients.
In this study, the investigators will follow the death 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 dead patients.
The end point of this study will be anesthesia death rate inside the hospital.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent anesthesia and surgery and died inside the hospital
Key inclusion criteria (2 listed)
- Patients who underwent anesthesia and surgery.
- Patients who died inside the hospital.
Key exclusion criteria (2 listed)
- Patient who underwent anesthesia and surgery and do not died and discharged home.
- Patients who died outside the hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesia related deathsnumber of anesthetized patients who died in the perioperative period inside the hospital | Other | – |
Primary outcome
number of anesthetized patients who died in the perioperative period inside the hospital
Time frame: 30 days post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Background: PubMed 24841805Watters 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.
- 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
Jordan University
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 Sudden Death, 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 2 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 12 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?
Contact Subhi M Alghanem, FFARCS (00962795640592, alghanem@ju.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of anesthetized patients who died in the perioperative period inside the hospital (time frame: 30 days post-operative). 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 NCT02732067, 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 12 Apr 2016.