NCT02512770

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

July 26, 2015

Last Update Submit

July 30, 2015

Conditions

Obstruction of EsophagusRespiratory ComplicationHemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • peak inspiratory pressure

    at time of endoscopy(0-40minute)

Secondary Outcomes (5)

  • complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)

    at time of endoscopy and after the endoscopy within 2 hours

  • Sp02

    at time of endoscopy and after the endoscopy within 2 hours

  • pressure levels for target tidal volume

    at time of endoscopy(0-40minute)

  • mean arterial pressure-mmHg

    at time of endoscopy(0-40minute)

  • heart rate-per/min

    at time of endoscopy(0-40minute)

Study Arms (2)

dilatation

EXPERIMENTAL

esaphageal dilatation group

Procedure: endoscopic dilatation

control

NO INTERVENTION

control group ( only endoscopy for control)

Interventions

endoscopic dilatationPROCEDURE
dilatation

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • endoscopy for esaphageal dilatation and control
  • ASA I-III
  • year old

You may not qualify if:

  • ASA IV
  • endoscopy for removing foreing body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Guner Kaya, Prof.

    Deapartment of Anesthesiology and Intensive Care, Cerrahpasa Medical Faculty,Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.(Anesthesiology Specialist)

Study Record Dates

First Submitted

July 26, 2015

First Posted

July 31, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07