NCT04196361

Brief Summary

This study evaluates thickening fraction alone and together with other ultrasound parameters of heart and lungs as predictors for extubation outcome

Trial Health

100
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

December 9, 2019

Last Update Submit

December 10, 2019

Conditions

Exutbation FailureMechanical Ventilation

Keywords

UltrasoundDiaphragmHolisticExtubation

Outcome Measures

Primary Outcomes (4)

  • Sensitivity

    Sensitivity of thickening fraction for extubation failure

    48 hours

  • Specificity

    Specificity of thickening fraction for extubation failure

    48 hours

  • Area under the Curve

    Area under the receiver operator curve

    48 hours

  • Correlation of ultrasound variables with extubation outcome

    Correlation of ultrasound variables with extubation outcome through (logistic)regression analysis.

    48 hours

Study Arms (1)

Ventilated72h

Patient that were ventilated for at least 72 hours

Diagnostic Test: Ultrasound

Interventions

UltrasoundDIAGNOSTIC_TEST

Point of care ultrasound as part of routine physical examination

Ventilated72h

Eligibility Criteria

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

The study population consisted of adult (\>18 years) patients, admitted to the ICU and ventilated for at least 72h.

You may qualify if:

  • Ventilated for \> 72 hours
  • Passed spontaneous breathing trial

You may not qualify if:

  • Planned NIV
  • Palliative Extubation
  • Tracheostomy
  • Paraplegia above Th 8

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haaksma ME, Smit JM, Heldeweg M, Nooitgedacht JS, Atmowihardjo LN, Jonkman AH, de Vries HJ, Lim EH, Steenvoorden T, Lust E, Girbes AR, Heunks LM, Tuinman PR. Holistic Ultrasound to Predict Extubation Failure in Clinical Practice. Respir Care. 2021 Jun;66(6):994-1003. doi: 10.4187/respcare.08679. Epub 2021 Apr 13.

    PMID: 33850048DERIVED

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 12, 2019

Study Start

September 1, 2016

Primary Completion

November 29, 2019

Study Completion

December 2, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

Upon we request we can share our data to assist other researchers with interest in this field of research.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After publication in a peer reviewed journal