NCT02350933

Brief Summary

The purpose of this study is to determine whether possible damages of the trachea caused by a prior prolonged intubation (\> 24h) can be observed by rigid endoscopy of the trachea and if cuffed tracheal tubes cause less damages than cuffed tubes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
4 countries

5 active sites

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

September 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

6.3 years

First QC Date

December 12, 2014

Last Update Submit

May 3, 2018

Conditions

IntubationEndoscopy

Keywords

tracheal damages

Outcome Measures

Primary Outcomes (1)

  • Number of patients with evidence of subglottic stenosis after longterm intubation with cuffed versus uncuffed tracheal tubes

    An International Study Board Committee (assessor board) will assess the endoscopic records in a blinded manner using a systematic grading system.

    After an average induction period of 10 min of an anesthesia with a planned intubation after the endoscopy

Secondary Outcomes (10)

  • Numbers of prior intubations

    Retrospective data analysis of former intubations is performed within two years after the endoscopy

  • Duration of prior longterm intubation

    Retrospective data analysis of former intubations is performed within two years after the endoscopy

  • Reason for prior longterm intubation

    Retrospective data analysis of former intubations is performed within two years after the endoscopy

  • Route of prior longterm intubation

    Retrospective data analysis of former intubations is performed within two years after the endoscopy

  • Tube type used for prior longterm intubation

    Retrospective data analysis of former intubations is performed within two years after the endoscopy

  • +5 more secondary outcomes

Study Arms (1)

0° rigid endoscope

OTHER

Endoscopy of the trachea is performed using a 0° rigid endoscope

Procedure: Endoscopy

Interventions

EndoscopyPROCEDURE

A rigid endoscopy of the larynx and the trachea until the carina is performed using a rigid 0° endoscope.

0° rigid endoscope

Eligibility Criteria

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

You may not qualify if:

  • No known risk for regurgitation
  • Written parental consent
  • American Society of Anesthesiologists (ASA) physical status \< IV
  • No parental written consent
  • Known airway anomalies associated with syndromes
  • Known or suspected difficult intubation
  • Emergency surgery or intervention
  • Full stomach and/or at risk for regurgitation
  • ASA physical status IV and higher
  • Patients with current or prior tracheostomy
  • Known, suspected or potential cervical spine pathology (e.g. Down's Syndrome)
  • Insufficient clinical details from previous prolonged intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kinderkrankenhaus Amsterdamer Straße

Cologne, North Rhine-Westphalia, 50735, Germany

Location

Asklepios Kinderklinik Sankt Augustin

Sankt Augustin, North Rhine-Westphalia, 53757, Germany

Location

Erasmus Medical Center, Sophia Children's Hospital

Rotterdam, 3015, Netherlands

Location

University Children's Hospital

Zurich, 8032, Switzerland

Location

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Markus Weiss, Prof.

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

January 30, 2015

Study Start

September 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

DE(2)GB(1)NL(1)CH(1)