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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01078831
Other study ID # REK-HO Ref 191-01055, 03052001
Secondary ID
Status Completed
Phase N/A
First received March 1, 2010
Last updated November 10, 2010
Start date March 2002
Est. completion date April 2010

Study information

Verified date November 2010
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Ethics Committee
Study type Observational

Clinical Trial Summary

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


Description:

Mechanically ventilated patients often need bronchoscopy as a diagnostic procedure or for visually directed elimination of secretions. Partial endotracheal tube occlusion by the bronchoscope increases airflow resistance. Inhibition of inspiratory flow may be compensated for by augmented inspiratory pressure. Reduced expiratory flow however, cannot be compensated for by most ventilators and could lead to higher airway - and intrathoracic pressures that are not detected by pressure transducers in the ventilator tubing. In this study we compare changes in ventilation, airway pressures, ventilator pressures and blood gases during bronchoscopy of intubated patients in both volume controlled and pressure controlled ventilation. Our hypothesis are that 1) increased resistance in the tube during bronchoscopy leads to high intrabronchial airway pressures when the ventilator is in volume controlled mode, and 2) when the ventilator is in pressure controlled mode, increased resistance in the tube during bronchoscopy leads to reduced Tidal Volume and moderately increased paCO2.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- ARDS/ALI patients on mechanical ventilation

- endotracheal tube size 7-9mm

- age > 18 years

- therapeutic or diagnostic bronchoscopy requested by staff physician

Exclusion Criteria:

- SpO2 < 90%

- unstable BP

- pneumothorax

- acute cardiovascular disease

- cerebrovascular or other condition that requires stable BP and saturation

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Bronchoscopy
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.

Locations

Country Name City State
Norway Oslo University Hospital - Ulleval Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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