Obstruction of EsophagusNCT02512770
Hemodynamic and Respiratory Effects of Esophageal Dilation in Children
A study testing endoscopic dilatation in people with Obstruction of Esophagus and Respiratory Complication, run by Istanbul University.
Trial summary
The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Obstruction of Esophagus, Respiratory Complication, Hemodynamic Instability
- What is being tested?
- endoscopic dilatation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- endoscopy for esaphageal dilatation and control
- ASA I-III
- 0-16 year old
Who cannot join
- ASA IV
- endoscopy for removing foreing body
About this study
Official title: Esaphageal Balloon Dilatation in Children: Hemodynamic , Ventilatory Changes and Complications
The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.
Read the detailed description
Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.
The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.
- Being tested
- endoscopic dilatation
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic dilatationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| dilatation | Experimental | esaphageal dilatation group Receives: Procedure: endoscopic dilatation |
| control | No intervention | control group ( only endoscopy for control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak inspiratory pressure
Measured: at time of endoscopy(0-40minute)
Secondary outcomes (5)
complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)
Measured: at time of endoscopy and after the endoscopy within 2 hours
Sp02
Measured: at time of endoscopy and after the endoscopy within 2 hours
pressure levels for target tidal volume
Measured: at time of endoscopy(0-40minute)
mean arterial pressure-mmHg
Measured: at time of endoscopy(0-40minute)
heart rate-per/min
Measured: at time of endoscopy(0-40minute)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstruction of EsophagusStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Ayse Cigdem Tutuncu, Senol Emre, Fatis Altindas, Kaya, Guner, M.D.
- Responsible party
- Principal investigator, pinar kendigelen, Istanbul University
- Investigators
- Guner Kaya, Prof., Study director, Deapartment of Anesthesiology and Intensive Care, Cerrahpasa Medical Faculty,Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512770
- Sponsor's protocol ID
- 270718
- Status last verified
- Jul 2015
- First submitted
- 26 Jul 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esaphageal Balloon Dilatation in Children: Hemodynamic , Ventilatory Changes and Complications
- ClinicalTrials.gov ID
- NCT02512770
- Acronym / sponsor ID
- 270718
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Ayse Cigdem Tutuncu, Senol Emre, Fatis Altindas, Kaya, Guner, M.D.
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Jul 2015 (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.
The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.
Detailed description
Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.
The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dilatation | Experimental | Procedure: endoscopic dilatationesaphageal dilatation group |
| control | No intervention | –control group ( only endoscopy for control) |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- endoscopy for esaphageal dilatation and control
- ASA I-III
- 0-16 year old
Key exclusion criteria (2 listed)
- ASA IV
- endoscopy for removing foreing body
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 |
|---|---|---|
| endoscopic dilatation | Procedure or surgery | dilatation |
Primary outcome
peak inspiratory pressure
Time frame: at time of endoscopy(0-40minute)
5 secondary outcomes
complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)
Time frame: at time of endoscopy and after the endoscopy within 2 hours
Sp02
Time frame: at time of endoscopy and after the endoscopy within 2 hours
pressure levels for target tidal volume
Time frame: at time of endoscopy(0-40minute)
mean arterial pressure-mmHg
Time frame: at time of endoscopy(0-40minute)
heart rate-per/min
Time frame: at time of endoscopy(0-40minute)
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 31 Jul 2015.
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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.
Guner Kaya, Prof. study director
Deapartment of Anesthesiology and Intensive Care, Cerrahpasa Medical Faculty,Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic dilatation in people with Obstruction of Esophagus and Respiratory Complication, run by Istanbul 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 3 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: finished, as of the sponsor's last update on 31 Jul 2015. 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?
peak inspiratory pressure (time frame: at time of endoscopy(0-40minute)). 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 31 Jul 2015.