Multicenter Prospective Observational Study on Diaphragmatic Function Assessment by Ultrasound in Patients with Acute Respiratory Failure Receiving Non-invasive Mechanical Ventilation or High Flow Nasal Canula

NCT06892912 | Not Yet Recruiting DMC

• 1 other identifier: CBE03_2025
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary goal of this study is to assess diaphragm function in patients with acute respiratory failure before and during the use of high-flow oxygen and/or non-invasive breathing support. The key question it seeks to answer is: 1\. How do ultrasound measurements of diaphragmatic function vary with different levels of breathing support in patients with acute respiratory failure? Participants with acute respiratory failure will undergo diaphragmatic ultrasound evaluation as part of their standard medical care at various levels of respiratory support.

Conditions

Respiration Disorders

Keywords

Respiratory failure; Diaphragmatic ultrasound; Respiratory support

Outcome Measures

Primary Outcomes (1)

• Correlation of Diaphragmatic Function (Excursion and Thickening Fraction) with Ventilatory Support Effectiveness in Patients with Acute Respiratory Failure

  To evaluate the relationship between diaphragmatic function measured by ultrasound (excursion and thickening fraction) prior to and during the administration of non-invasive respiratory support. This evaluation will focus on the effectiveness of ventilatory support in terms of improvement in respiratory mechanics parameters and the reduction in the need for orotracheal intubation in patients with acute respiratory failure (hypoxemic/hypercapnic).

  From enrollment to ICU discharge (aprox. 2 weeks)

Secondary Outcomes (1)

• Correlation of Diaphragmatic Function (Excursion and Thickening Fraction) with Respiratory Mechanics, Ventilation Duration, and ICU Mortality in Patients with Acute Respiratory Failure

  From enrollment to ICU discharge (aprox. 2 weeks)

Study Arms (1)

Patients with acute respiratory failure

Patients with acute respiratory failure (e.g., hypoxemic or hypercapnic) who require non-invasive mechanical ventilation or high-flow nasal canula.

Other: Diaphragmatic ultrasound

Interventions

Diaphragmatic ultrasound OTHER

Sample: Given the observational nature of the study, a convenience sample will be obtained from all patients admitted to the emergency services and/or ICU with respiratory failure over the course of 1 year. Inclusion Criteria: * Age ≥ 18 years * Hypoxemic respiratory failure (SpO2 \< 88% - PaO2 \< 60 mmHg) or hypercapnic (PaCO2 \> 40) * Need for NIMV and/or HFNC. Exclusion Criteria: * Neuromuscular disease * Pregnancy * Tracheostomy * Rib fractures * Cervical injuries * Diaphragmatic paralysis * Diaphragmatic malformations * Hemodynamic instability * Morbid obesity (BMI \> 35) * Use of sedation and neuromuscular relaxants * Pneumothorax or pneumomediastinum * Poor acoustic window * Critically ill patients with a prognosis of less than 24 hours of life * Patients receiving palliative interventions.

Patients with acute respiratory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute respiratory failure in the emergency department or intensive care unit (ICU).

You may qualify if:

• Age ≥ 18 years
• Hypoxemic respiratory failure (SpO2 \< 88% - PaO2 \< 60 mmHg) or hypercapnic (PaCO2 \> 40)
• Need for NIMV and/or HFNC.

You may not qualify if:

• Neuromuscular disease
• Pregnancy
• Tracheostomy
• Rib fractures
• Cervical injuries
• Diaphragmatic paralysis
• Diaphragmatic malformations
• Hemodynamic instability
• Morbid obesity (BMI \> 35)
• Use of sedation and neuromuscular relaxants
• Pneumothorax or pneumomediastinum
• Poor acoustic window
• Critically ill patients with a prognosis of less than 24 hours of life Patients receiving palliative interventions.

Sponsors & Collaborators

• Foro Internacional en Cuidado Crítico: lead

MeSH Terms

Conditions

Respiration Disorders; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Carlos A Santacruz H, MD, PhD

  Foro Internacional en Cuidado Crítico

  STUDY DIRECTOR

Central Study Contacts

Carlos A Santacruz H, MD, PhD

CONTACT

+57 318 8371125; administracion@ficc.com.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 25, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share