NCT02997072

Brief Summary

The purpose of this study is attempt to establish optimum drive pressure of high frequency jet ventilation during rigid bronchoscopy to ensure good aeration of the lungs examined by electrical impedance tomography.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

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

July 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

2.4 years

First QC Date

December 15, 2016

Last Update Submit

December 15, 2016

Conditions

Thoracic Diseases

Keywords

electrical impedance tomographyhigh frequency jet ventilationdrive pressure

Outcome Measures

Primary Outcomes (1)

  • Lung aeration corresponding to each layer of the lungs.

    The numerical values indicating the percentage of total increased resistance corresponding to each layer of the lungs (ROI - region of interests) that were collected in 15-seconds intervals.

    10 minutes

Eligibility Criteria

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

Group of 30 patients hospitalized in 1st Clinical Hospital in Zabrze that were qualified for planned thoracotomy or videothoracoscopy with the preceding rigid bronchoscopy procedure.

You may qualify if:

  • Older than 18
  • Obtained written consent form to participate in research
  • Patients qualified for rigid bronchoscopy procedure

You may not qualify if:

  • Absence of the written consent to participate in research
  • Undergoing urgent treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bialka S, Copik M, Rybczyk K, Owczarek A, Jedrusik E, Czyzewski D, Filipowski M, Rivas E, Ruetzler K, Szarpak L, Misiolek H. Assessment of changes of regional ventilation distribution in the lung tissue depending on the driving pressure applied during high frequency jet ventilation. BMC Anesthesiol. 2018 Jul 31;18(1):101. doi: 10.1186/s12871-018-0552-2.

    PMID: 30064377DERIVED

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Hanna Misiołek, MD, PhD, Prof

    School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 19, 2016

Study Start

July 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share