Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07423338

Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients Requiring Non-invasive Respiratory Support (MONITOR-NIV): A Prospective Observational Study

Led by Queen Mary University of London · Updated on 2026-05-22

50

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute respiratory failure is a life-threatening condition where the lungs cannot supply enough oxygen to the body. Many patients receive non-invasive respiratory support (NRS) like high-flow nasal oxygen, CPAP, or BiPAP, but up to half still worsen and need invasive ventilation, which can cause longer hospital stays and complications. This research investigates whether two advanced, non-invasive, radiation-free tools—ultrasound and electrical impedance tomography (EIT)—can be effectively used at the bedside to monitor breathing muscle function and lung changes in patients on NRS outside intensive care settings. Participants will undergo repeated ultrasound and EIT assessments up to seven times during the first 72 hours after starting NRS, with an additional measurement if they improve or worsen. Ultrasound measures muscle thickness, movement, and lung aeration, while EIT uses electrodes around the chest to monitor lung air and blood flow continuously. Clinical staff involved in patient care will also complete questionnaires and may participate in interviews to evaluate how useful and practical these monitoring tools are in clinical decision-making. Throughout the study, routine clinical data such as heart rate, oxygen levels, respiratory rate, and treatment settings will be recorded alongside the advanced monitoring results. Researchers will assess the usability of these tools for clinicians, track changes in respiratory muscles and lungs over time, and explore links between these changes and treatment outcomes like intubation or death. Participation lasts during the early phase of NRS, with multiple assessments and safety measures to ensure patient comfort and data quality.

CONDITIONS

Brief Title

Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients on Non Invasive Respiratory Support

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult 18 years or older
  • Diagnosed with acute respiratory failure with low oxygen levels (PaO2 <8.0 kPa) and/or high carbon dioxide levels (PaCO2 >6.0 kPa) from any cause
  • Requiring any non-invasive respiratory support such as high-flow nasal oxygen, CPAP, or BiPAP
  • Multidisciplinary critical care staff involved in managing recruited patients may participate in interviews and questionnaires
Not Eligible

You will not qualify if you...

  • In respiratory arrest with no airflow or breathing effort
  • Requiring immediate intubation
  • Glasgow Coma Scale less than 8
  • Severe facial trauma or burns
  • Fixed upper airway obstruction or inability to protect airway
  • Severe agitation or confusion preventing use of device mask
  • Severe vomiting
  • Pregnancy
  • Presence of pacemakers or other electronic devices in the chest
  • Receiving end-of-life or palliative care
  • Contraindications to ultrasound or electrical impedance tomography such as burns, severe obesity, thoracic wounds, or chest drains

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 3 days (72 hours)

Participants receiving non-invasive respiratory support undergo serial non-invasive respiratory muscle and lung function monitoring using ultrasound and electrical impedance tomography across six time points within the first 72 hours.

6 monitoring time points over 3 days

Usability Assessment

Duration - Up to 3 days (72 hours)

Clinical staff involved in participant care complete usability assessments of the monitoring data using the Healthcare System Usability Scale at two time points to evaluate effectiveness and integration into clinical decision making.

2 assessments during the monitoring period

Trial Site Locations

Total: 2 locations

1

Royal London Hospital

London, United Kingdom, E1 1BB

Actively Recruiting

2

Newham Hospital

London, United Kingdom

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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