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Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions

This study is currently recruiting participants.
Verified May 2011 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Espen Rostrup Nakstad, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01239433
First received: November 10, 2010
Last updated: January 12, 2013
Last verified: May 2011
History of Changes
  Purpose

Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation.


Condition
Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Intrabronchial airway pressure [ Time Frame: 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
mechanically ventilated patients
ICU patients on mechanical ventilation. Daily endotracheal suctioning performed to reduce secretions. Data recorded during these therapeutic interventions.

Detailed Description:

Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study such pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation. A systematic recording of airway pressures, tidal volumes and blood gases are carried out during ordinary therapeutic procedures requested by the staff physician. No additional study interventions are carried out.

The aim of the project is to examine negative effects of pressure/volume changes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients in the Intensive Care Unit (ICU) on mechanical ventilation where daily endotracheal suctioning is performed to remove secretions.

Most of the patients have ARDS/ ALI.

Criteria

Inclusion Criteria:

  • > 18 years of age
  • on mechanical ventilation
  • daily endotracheal suctioning performed

Exclusion Criteria:

  • < 18 years of age
  • non-invasive ventilation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239433

Contacts
Contact: Espen R Nakstad, MD +47 22 11 91 01 naes@uus.no
Contact: Helge Opdahl, MD, PhD +47 22 11 91 01 heop@uus.no

Locations
Norway
Oslo University Hospital - Ulleval Recruiting
Oslo, Norway, 0407
Contact: Espen R Nakstad, MD     +47 22 11 91 01     naes@uus.no    
Contact: Helge Opdahl, MD, PhD     +47 22 11 91 01     heop@uus.no    
Principal Investigator: Espen R Nakstad, MD            
Sub-Investigator: Helge Opdahl, MD, PhD            
Sub-Investigator: Fredrik Borchsenius, MD            
Sub-Investigator: Ole H Skjoensberg, MD, PhD            
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Espen R Nakstad, MD Oslo University Hospital - Ulleval, Norway
Study Director: Helge Opdahl, MD, PhD Oslo University Hospital Ulleval
  More Information

No publications provided

Responsible Party: Espen Rostrup Nakstad, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01239433     History of Changes
Other Study ID Numbers: REK S-O, Ref 2010/1340, part B
Study First Received: November 10, 2010
Last Updated: January 12, 2013
Health Authority: Norway: Regional Ethics Commitee

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013