NCT02901158

Brief Summary

Esophageal pressure measurements are used in to determine chest wall elastance and calculate lung elastance and transpulmonary pressure in mechanically ventilated patients. A dedicated esophageal balloon catheter is then placed in the esophagus to measure tidal variations in esophageal pressure. In this study high resolution solid-state manometry technique was used to provide detailed and continuous measurements of esophageal pressures in the different parts of the esophagus. Measurements were performed during ongoing mechanical ventilation at different levels of endexpiratory pressure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

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

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

September 9, 2016

Last Update Submit

October 10, 2018

Conditions

Acute Respiratory Failure

Keywords

esophageal pressurechest wall elastancelung elastancetranspulmonary pressure

Outcome Measures

Primary Outcomes (1)

  • Esophageal pressure measurements in mechanically ventilated patients

    Esophageal pressure was measured in mechanically ventilated patients in the critical care unit and in the operating room.

    Within one hour

Study Arms (2)

Critical care patients

Mechanically ventilated patients in the critical care unit

OR-patients

Mechanically ventilated patients in the operating room

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mechanically ventilated patients in the critical care unit and in the operating room.

You may qualify if:

  • Patients in the critical care unit receiving mechanical ventilation or Patients anesthetized and undergoing surgery

You may not qualify if:

  • Patients with a contraindication to insert a catheter in the esophagus for instance due to an operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

Location

Related Publications (1)

  • Persson P, Ahlstrand R, Gudmundsson M, de Leon A, Lundin S. Detailed measurements of oesophageal pressure during mechanical ventilation with an advanced high-resolution manometry catheter. Crit Care. 2019 Jun 13;23(1):217. doi: 10.1186/s13054-019-2484-8.

    PMID: 31196203DERIVED

Study Officials

  • Stefan Lundin, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

May 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)