NCT01786642

Brief Summary

The aim of the present study is to measure the time to correction of O2 saturation when in case of desaturation below 90%, O2 administration is switched from the nasal to the tracheal route at a similar flow rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

February 1, 2013

Last Update Submit

February 6, 2013

Conditions

Hypoxaemia

Outcome Measures

Primary Outcomes (1)

  • Time to correction of SpO2

    procedure

Study Arms (2)

conscious

bronchoscopy without sedative drugs

conscious sedation

bronchoscopy under midazolam

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients referred for flexible bronchoscopy

You may qualify if:

  • patients referred for flexible bronchoscopy

You may not qualify if:

  • broncho-alveolar lavage
  • endobronchial plugging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospitals leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe Dooms, Md PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY DIRECTOR

Central Study Contacts

Jonas Yserbyt, MD

CONTACT

+3216346801jonas.yserbyt@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 8, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

BE(1)