AnesthesiaNCT03244436
Emergency Surgery Following Pediatric Catheterization
An observational study of Anesthesia, run by Cairo University.
Trial summary
We study the outcome and prequesties of emergency surgeries that were necessary following accidents in the pediatric cardiac catheterization lab Read more about this study
- Who is it for?
- Ages 2 months to 9 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Surgery following catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2013to 15 Jun 2015
- 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 2 months to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: 190 pediatric patients presenting for either diagnostic or interventional cardiac catheterization
Who may be able to join
- patients presenting for diagnostic or therapeutic pediatric cardiac catheterization
Who cannot join
- none
About this study
Official title: Emergency Surgery Following Pediatric Cardiac Catheterization
We study the outcome and prequesties of emergency surgeries that were necessary following accidents in the pediatric cardiac catheterization lab
- Conditions
- Anesthesia
- Being tested
- Surgery following catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery following catheterizationProcedure or surgery
Emergency surgery following pediatric cardiac catheterization
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge from ICU
Measured: A 2 years study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start15 Jun 2013
- Primary completion15 Jun 2015
- Study completion15 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kareem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244436
- Sponsor's protocol ID
- Surgery after catheterization
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Surgery Following Pediatric Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT03244436
- Acronym / sponsor ID
- Surgery after catheterization
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2013 (actual)
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- 15 Jun 2015 (actual)
- First posted
- 9 Aug 2017 (actual)
- 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.
We study the outcome and prequesties of emergency surgeries that were necessary following accidents in the pediatric cardiac catheterization lab
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 190 pediatric patients presenting for either diagnostic or interventional cardiac catheterization
Key inclusion criteria (1 listed)
- patients presenting for diagnostic or therapeutic pediatric cardiac catheterization
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Surgery following catheterizationEmergency surgery following pediatric cardiac catheterization | Procedure or surgery | – |
Primary outcome
Discharge from ICU
Time frame: A 2 years study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingObservational study
COMparative Performance of General Purpose Models
Neurosurgical Patients
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Cairo University.
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 1 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: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Discharge from ICU (time frame: A 2 years study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2017.