Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01078831
First received: March 1, 2010
Last updated: November 10, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention
Acute Respiratory Distress Syndrome
Acute Lung Injury (ALI)
Other: Bronchoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy Under Volume Controlled (VC) and Pressure Controlled (PC) Ventilation

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Changes in ventilation, airway pressures and blood gases after bronchoscope insertion. [ Time Frame: 2 minutes after bronchoscope insertion/ mode change ] [ Designated as safety issue: Yes ]
    paO2, paCO2 (kPa), airway and ventilator pressures (cmH2O)


Biospecimen Retention:   Samples Without DNA

Arterial blood gases


Estimated Enrollment: 20
Study Start Date: March 2002
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ARDS / ALI patients 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078831

Locations
Norway
Oslo University Hospital - Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Helge Opdahl, MD, PhD Oslo University Hospital - Ulleval, Norway
Study Director: Ole H Skjønsberg, MD, PhD Oslo University Hospital Ulleval
Study Director: Fredrik Borchsenius, MD Oslo University Hospital Ulleval
  More Information

No publications provided

Responsible Party: Fredrik Borchsenius, MD, Head of Department for Pulmonary Medicine, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01078831     History of Changes
Other Study ID Numbers: REK-HO Ref 191-01055, 03052001
Study First Received: March 1, 2010
Last Updated: November 10, 2010
Health Authority: Norway: Ethics Committee

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014