NCT01078831

Brief Summary

The purpose of this study is to examine changes in ventilation and airway pressures during conventional bronchoscopy of intubated patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2002

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 11, 2010

Status Verified

November 1, 2010

Enrollment Period

8.1 years

First QC Date

March 1, 2010

Last Update Submit

November 10, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in ventilation, airway pressures and blood gases after bronchoscope insertion.

    paO2, paCO2 (kPa), airway and ventilator pressures (cmH2O)

    2 minutes after bronchoscope insertion/ mode change

Study Arms (1)

ARDS / ALI patients

Other: Bronchoscopy

Interventions

Airway pressures, ventilation changes and blood gas changes are recorded in a group of intubated patients on mechanical ventilation before and after bronchoscope insertion. The registration is done immediately before a therapeutic/diagnostic bronchoscopy requested by a staff physician not involved n the study.

ARDS / ALI patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ARDS/ALI patients on mechanical ventilation where a therapeutic or diagnostic bronchoscopy has been requested by the staff physician.

You may qualify if:

  • ARDS/ALI patients on mechanical ventilation
  • endotracheal tube size 7-9mm
  • age \> 18 years
  • therapeutic or diagnostic bronchoscopy requested by staff physician

You may not qualify if:

  • SpO2 \< 90%
  • unstable BP
  • pneumothorax
  • acute cardiovascular disease
  • cerebrovascular or other condition that requires stable BP and saturation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital - Ulleval

Oslo, Oslo County, 0407, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Arterial blood gases

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Helge Opdahl, MD, PhD

    Oslo University Hospital - Ulleval, Norway

    STUDY DIRECTOR
  • Ole H Skjønsberg, MD, PhD

    Ullevaal University Hospital

    STUDY DIRECTOR
  • Fredrik Borchsenius, MD

    Ullevaal University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

March 1, 2002

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

November 11, 2010

Record last verified: 2010-11

Locations