NCT01239433

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

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

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

November 10, 2010

Last Update Submit

September 26, 2016

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Intrabronchial airway pressure

    2013

Study Arms (1)

mechanically ventilated patients

ICU patients on mechanical ventilation. Daily endotracheal suctioning performed to reduce secretions. Data recorded during these therapeutic interventions.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • \< 18 years of age
  • non-invasive ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital - Ulleval

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Espen R Nakstad, MD

    Oslo University Hospital - Ulleval, Norway

    PRINCIPAL INVESTIGATOR

  • Helge Opdahl, MD, PhD

    Ullevaal University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

May 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

NO(1)