NCT06706830

Brief Summary

The goal of this observational study is to evaluate whether the risk of intubation in patients with hypoxemic respiratory failure who were monitored in the intensive care unit and received non-invasive mechanical ventilation and high-flow nasal oxygen treatment could be predicted using lung and diaphragm ultrasound. The main question it aims to answer is: Can lung and diaphragm ultrasound predict the risk of intubation in patients with hypoxemic respiratory failure?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 11, 2024

Last Update Submit

November 22, 2024

Conditions

Diaphragm UltrasonographyLung UltrasoundHypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Lung and diaphragm ultrasound evaluation for risk of intubation

    Lung and diaphragm ultrasound can predict risk of intubation

    48 hours

Secondary Outcomes (2)

  • ROX index evaluation for risk of intubation

    48 hours

  • LUSS/ROX index ratio evaluation for risk of intubation

    48 hours

Study Arms (1)

Hypoxemic

Patients whose partial oxygen levels are low

Eligibility Criteria

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

Hypoxemic patients in intensive care unit

You may qualify if:

  • PaO2 \<60 mmHg detected in arterial blood gas samples at the time of admission to the intensive care unit

You may not qualify if:

  • Under the age of 18
  • History of lung and diaphragm surgery
  • Congenital, acquired or traumatic diaphragmatic hernia
  • Diaphragm paralysis
  • Hemodynamic instability requiring vasoactive drug support
  • Do not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prof. Dr. Cemil Tascıoglu City Hospital

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Namigar Turgut

    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 27, 2024

Study Start

January 1, 2024

Primary Completion

May 1, 2024

Study Completion

August 23, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

TU(2)