NCT02948530

Brief Summary

Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. The measurements are performed in sedated and mechanically ventilated patients in the intensive care unit.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

October 26, 2016

Last Update Submit

April 10, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of lung elastance and transpulmonary pressure

    Comparison of a new versus the classical method for measurement of transpulmonary pressure

    Within one hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sedated and mechanically ventilated patients in the intensive care unit

You may qualify if:

  • Mechanically ventilated patients in the intensive care unit

You may not qualify if:

  • Patients with chronic obstrucive lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stefan Lundin, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Lundin, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations