NCT07423338

Brief Summary

Acute respiratory failure is a common, life-threatening condition where the lungs cannot provide enough oxygen to the body. Many patients are treated with non-invasive respiratory support (NRS) such as high-flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP). However, up to half of patients receiving NRS still deteriorate and require intubation and invasive ventilation, which is linked to longer hospital stays, more complications, and slower recovery. A major challenge in caring for these patients is that clinicians currently cannot directly see how well the breathing muscles (especially the diaphragm and parasternal intercostal muscles) and the lungs are working while the patient is using NRS. Existing bedside measures, such as respiratory rate or oxygen levels, only show part of the picture. They do not indicate how hard the patient is working to breathe or whether their respiratory muscles are becoming fatigued. This lack of information may delay important decisions about adjusting NRS settings or switching to other treatments. This study aims to find out whether two advanced but non-invasive, radiation-free bedside monitoring tools can be used effectively in routine care:

  • how the respiratory muscles and lungs change over time during NRS
  • whether these changes are linked to treatment settings (e.g., flow rate, pressure support)
  • whether certain patterns are associated with treatment success or failure (intubation or death)
  • whether these tools could help identify patients at risk of deterioration earlier Risks and benefits: Both ultrasound and EIT are widely used, safe, and non-invasive. They involve no radiation, needles, or harmful exposure. Minor temporary discomfort from the gel or belt placement is possible. Participation will not change any clinical treatments. Although patients may not directly benefit, the study may help future patients by improving understanding of breathing muscle function and supporting more personalised respiratory care. By contributing to this research, patients and clinicians will help determine whether advanced monitoring can be realistically implemented in busy hospital settings and whether it could lay the groundwork for future trials aimed at improving outcomes for people with acute respiratory failure.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress25%
Feb 2026May 2027

First Submitted

Initial submission to the registry

January 5, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

January 5, 2026

Last Update Submit

May 20, 2026

Conditions

Non Invasive VentilationAcute Respiratory Failure (ARF)

Keywords

acute respiratory failurenon-invasive respiratory supportultrasonographyelectrical impedance tomography

Outcome Measures

Primary Outcomes (1)

  • Usability

    The usability of respiratory muscle ultrasound and electrical impedance tomography to effectively support clinical decision making measured by asking clinical staff to complete the Healthcare System Usability Scale (HSUS). The Healthcare System Usability Scale (HSUS) will be used to assess usability, which score is converted into percentage in a system ranging from 0 to 100 for rating of usability to allow interpretation. Acceptability scales range: "Not Acceptable"\< 50, "Marginally acceptable" 50-70, "Acceptable"\> 70.

    72 hours

Secondary Outcomes (2)

  • Feasibility evaluation

    72 hours

  • Observational evaluation

    72 hours

Study Arms (1)

Patients with acute respiratory failure requiring non invasive respiratory support

OTHER

Patients with acute respiratory failure requiring non invasive respiratory support

Other: Advanced respiratory monitoring

Interventions

Advanced respiratory monitoringOTHER

1. Ultrasound assessments or lungs and respiratory muscles: Respiratory muscle and lung ultrasound will be performed using GE Venue Go devices with linear or phased array probes. 2. Electrical Impedance Tomography EIT will be performed using the INFIVISION ET1000 system. A 16-electrode belt will be placed at the 5th-6th intercostal space. 3. Usability Assessments Clinical staff directly involved in patient management will complete the Healthcare System Usability Scale (HSUS).

Also known as: electrical impedance tomography, ultrasonography, usability
Patients with acute respiratory failure requiring non invasive respiratory support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥18 years old)
  • with acute respiratory failure with hypoxia (i.e. arterial oxygen tension (PaO2) of \<8.0 kPa), and/or with or without hypercapnia (i.e. arterial carbon dioxide tension (PaCO2) of \>6.0 kPa) from any underlying disease or cause
  • requiring any non-invasive respiratory support (i.e. HFNO, CPAP, BiPAP)
  • Multidisciplinary critical care staff involved in the management of those recruited patients with acute respiratory failure requiring non-invasive respiratory supports. Staff will possibly have an interview and are also required to complete a questionnaire.

You may not qualify if:

  • Patients in respiratory arrest defined as the total cessation of airflow and breathing effort and absent ventilation (24,25)
  • Patients requiring immediate intubation
  • Patients with Glasgow Coma Scale (GCS) \< 8
  • Patients with severe facial trauma or burns
  • Patients with fixed upper airway obstruction or inability to protect the airway
  • Patients with severe agitation and/or confusion that prevent use of the device mask
  • Patients with severe vomiting
  • Pregnancy
  • Patients with pacemakers and other electronic devices in the thorax
  • Patients on end-of-life care or palliative care (defined as expected to die and/or not receiving active treatment)
  • Contra-indication to EIT or ultrasound monitoring (e.g. burns, severe obesity, thoracic wounds limiting instrument placement, and thoracic drain)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal London Hospital

London, E1 1BB, United Kingdom

RECRUITING

Newham Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Interventions

High-Energy Shock WavesUser-Centered Design

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaEquipment DesignInvestigative TechniquesUniversal DesignEngineeringTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 20, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

May 2, 2027

Study Completion (Estimated)

May 2, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

GB(2)