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Hemodynamic and Respiratory Effects of Esophageal Dilation in Children

Esaphageal Balloon Dilatation in Children: Hemodynamic , Ventilatory Changes and Complications

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02512770
Enrollment
60
Registered
2015-07-31
Start date
2015-01-31
Completion date
2015-06-30
Last updated
2015-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Obstruction of Esophagus, Respiratory Complication

Brief 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.

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.

Interventions

PROCEDUREendoscopic dilatation

Sponsors

Ayse Cigdem Tutuncu
CollaboratorOTHER
Senol Emre
CollaboratorUNKNOWN
Fatis Altindas
CollaboratorUNKNOWN
Kaya, Guner, M.D.
CollaboratorINDIV
Istanbul University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

Inclusion criteria

* endoscopy for esaphageal dilatation and control * ASA I-III * 0-16 year old

Exclusion criteria

* ASA IV * endoscopy for removing foreing body

Design outcomes

Primary

MeasureTime frame
peak inspiratory pressureat time of endoscopy(0-40minute)

Secondary

MeasureTime frame
pressure levels for target tidal volumeat time of endoscopy(0-40minute)
mean arterial pressure-mmHgat time of endoscopy(0-40minute)
heart rate-per/minat time of endoscopy(0-40minute)
complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)at time of endoscopy and after the endoscopy within 2 hours
Sp02at time of endoscopy and after the endoscopy within 2 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026