The Role of Lung and Diaphragm Ultrasonography in Predict... | NCT06706830

Studies
The Role of Lung and Diaphragm Ultrasonography in Predicting Clinical Progression in Hypoxemic Respiratory Failure

NCT06706830

Sponsor

Simge Evren

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

91Actual

Phase

Not provided

Conditions

Diaphragm Ultrasonography
Lung Ultrasound
Hypoxemic Respiratory Failure

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

May 1, 2024Actual

Completion Date

Aug 23, 2024Actual

First Submitted Date

Nov 11, 2024

First Submission Date that Met QC Criteria

Nov 22, 2024

First Posted Date

Nov 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2024

Last Update Posted Date

Nov 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Simge Evren, Principal Investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationSponsor-Investigator

Lead Sponsor

Simge EvrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Between January 1, 2024, and May 1, 2024, the diaphragm thickness fraction, excursion, LUS score, ROX index, and the LUSS/ROX index ratio were evaluated using lung and diaphragm ultrasound in 91 patients admitted to the intensive care unit with a diagnosis of hypoxemic respiratory failure. These evaluations were performed at the 6th, 12th, 24th, and 48th hours of their ICU stay, and during intubation if the decision for intubation was made

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Label	Type	Description	Intervention Names
Hypoxemic		Patients whose partial oxygen levels are low

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung and diaphragm ultrasound evaluation for risk of intubation	Lung and diaphragm ultrasound can predict risk of intubation	48 hours

Secondary Outcomes

Measure	Description	Time Frame
ROX index evaluation for risk of intubation	The Respiratory Rate-Oxygenation Index can predict the risk of intubation Higher score means lower risk	48 hours
LUSS/ROX index ratio evaluation for risk of intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hypoxemic patients in intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Namigar Turgut	Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. Cemil Tascıoglu City Hospital		Istanbul	Şişli	34384	Turkey (Türkiye)
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided