PROTECT Airways: a research study to find out if an alternative airway system is better than standard of care for patients connected to a breathing machine

The clinical and cost-effectiveness of advanced airways protection device versus conventional endotracheal tubes in intensive care unit patients requiring mechanical ventilation: a multi-centre, pragmatic randomised clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15882946

Enrollment

2194

Registered

2025-02-21

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive care unit patients requiring mechanical ventilation Other

Interventions

Intervention: a CE-marked advanced airways protection device (Venner PneuX™) Control: standard of care endotracheal tube used at hospital. The randomisation system will be a secure web-based and al

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult (age =18 years) 2. Need for invasive mechanical ventilation 3. Likely to remain ventilated for at least 24 hours post-randomisation

Exclusion criteria

Exclusion criteria: 1. Treatment withdrawal anticipated over the next 24 hours 2. Presence of tracheostomy at screening 3. Intubated for more than 24 hours prior to randomisation

Design outcomes

Primary

Measure	Time frame
Duration of mechanical ventilation in days as measured from time from randomisation to first successful unassisted breathing, measured using data collected from medical records	—

Secondary

Measure	Time frame
1. Ventilator-associated pneumonia (VAP), diagnosed by treating clinician with the commencement of antibiotics from randomisation up to ICU discharge, using data collected from medical records. 2. Hospital-acquired pneumonia (HAP) following extubation: clinician diagnosis and commencement of antibiotics from randomisation up to ICU discharge, using data collected from medical records. 3. Reportable serious adverse events that occur between randomisation and time of hospital discharge, using data collected from medical records. 4. Pre-specified adverse events that occur between intubation and time of ICU discharge, using data collected from medical records. 5. Costs associated with the use of NHS & personal social services (PSS) resources arising during the hospital stay and after hospital discharge; personal expenditures (out-of-pocket costs) incurred by patients after hospital discharge. Collected from participants via questionnaire at 2 and 6 months following randomisation. 6. Health-related quality of life measured using a widely used and recommended preference-based quality of life instrument (EQ-5D-5L) collected from participants via questionnaire at 2 and 6 months following randomisation	—

Measure

Time frame

1. Ventilator-associated pneumonia (VAP), diagnosed by treating clinician with the commencement of antibiotics from randomisation up to ICU discharge, using data collected from medical records. 2. Hospital-acquired pneumonia (HAP) following extubation: clinician diagnosis and commencement of antibiotics from randomisation up to ICU discharge, using data collected from medical records. 3. Reportable serious adverse events that occur between randomisation and time of hospital discharge, using data collected from medical records. 4. Pre-specified adverse events that occur between intubation and time of ICU discharge, using data collected from medical records. 5. Costs associated with the use of NHS & personal social services (PSS) resources arising during the hospital stay and after hospital discharge; personal expenditures (out-of-pocket costs) incurred by patients after hospital discharge. Collected from participants via questionnaire at 2 and 6 months following randomisation. 6. Health-related quality of life measured using a widely used and recommended preference-based quality of life instrument (EQ-5D-5L) collected from participants via questionnaire at 2 and 6 months following randomisation

—

Countries

England, United Kingdom

Contacts

Public ContactPROTECT Airways Trial Manager

protectairways@warwick.ac.uk+44 (0) 2476 575 288

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026