- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01078831
Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy
November 10, 2010 updated by: Oslo University Hospital
Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy Under Volume Controlled (VC) and Pressure Controlled (PC) Ventilation
The purpose of this study is to examine changes in ventilation and airway pressures during conventional bronchoscopy of intubated patients.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0407
- Oslo University Hospital - Ullevål
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ARDS/ALI patients on mechanical ventilation where a therapeutic or diagnostic bronchoscopy has been requested by the staff physician.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ARDS / ALI patients
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in ventilation, airway pressures and blood gases after bronchoscope insertion.
Time Frame: 2 minutes after bronchoscope insertion/ mode change
|
paO2, paCO2 (kPa), airway and ventilator pressures (cmH2O)
|
2 minutes after bronchoscope insertion/ mode change
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Primary Completion (ACTUAL)
April 1, 2010
Study Completion (ACTUAL)
April 1, 2010
Study Registration Dates
First Submitted
March 1, 2010
First Submitted That Met QC Criteria
March 1, 2010
First Posted (ESTIMATE)
March 2, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 11, 2010
Last Update Submitted That Met QC Criteria
November 10, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK-HO Ref 191-01055, 03052001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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