ClinicalTrials.gg
WithdrawnNCT03140579APRVUpdated Aug 17, 2022

Effect of PEEP on Lung Recruitment and Homogeneity Over Time in Moderate to Severe ARDS

An observational study in ARDS, Critical Illness and Ventilator-Induced Lung Injury, sponsored by Guy's and St Thomas' NHS Foundation Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-17.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

Why this study was withdrawn
Study not undertaken due to COVID and capacity
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study evaluates the effect of airway pressure release ventilation (APRV) on lung homogeneity and recruitment in patients with moderate to severe acute respiratory distress syndrome (ARDS).

It will do this by comparing the homogeneity of ventilation and recruitment prior to a patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.

Read the detailed description

Ventilator-induced lung injury (VILI) is a well-recognised problem of ventilation in patients with ARDS, and is currently treated with lung-protective ventilation, which limits tidal volumes and airway pressures by applying higher levels of positive-end expiratory pressure (PEEP). However, it is not known whether higher levels of PEEP increases recruitment and homogeneity of ventilation within the lungs.

APRV is a mode of inverse ventilation, where high levels of PEEP are maintained with brief releases of pressure, and has been proposed as an appropriate method of ventilation in patients with ARDS.

This study will assess homogeneity of ventilation and recruitment in 15 patients before APRV is started, and 30, 60 and 120 mins after commencing APRV. It will do this using Electrical Impedance Tomography (EIT), nitrogen wash in/wash out technique, and lung strain.

02

Conditions studied

  • ARDS
  • Critical Illness
  • Ventilator-Induced Lung Injury

Keywords

  • recruitment
  • lung homogeneity
  • airway pressure release ventilation
03

In context

Critical Illness

1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.

Browse Critical Illness studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 294 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All Patients admitted to ICU ventilated with moderate or severe ARDS, based on the Berlin definition of ARDS.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years and \< 80 years

    • Weight > 35 Kg and BMI \< 40
    • Informed consent according to local regulations
    • Hemoglobin ≥ 70 g/dl
    • Haemodynamically stable > 4 hours
    • Moderate to severe ARDS (PaO2/FIO2 \< 26.6 kPa with positive end-expiratory pressure (PEEP) > 5 cmH2O) as per Berlin definition of ARDS

Exclusion criteria

Exclusion Criteria:

  • Expected survival \< 72 hours

    • Suspected pregnancy (negative pregnancy test required for women of child-bearing potential)
    • Open abdomen
    • Documented or suspected raised intracranial pressure
    • Active air leak (pneumothorax, pneumomediastinum, subcutaneous emphysema)
    • Morbid obesity BMI > 40
    • Recent \< 1 week cardiac or thoracic surgery
    • Unstable thorax and sternum with paradoxical chest wall movement
    • Severe Chronic Respiratory Disease (COPD) - GOLD 3 or 4 emphysema with bullae
    • Severe smoking (> 40 pack-year history)
    • Liver Failure: Child-Pugh Class C
    • Massive ascites
    • Lung fibrosis
    • Severe cardiac disease (one of the following): New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias
    • Sickle cell disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • OtherAPRV

    Airway pressure release ventilation is a method of inverse ventilation, where high levels of positive end expiratory pressure are maintained to optimise oxygenation with brief releases of pressure to allow ventilation and release carbon dioxide. It is an approved and frequently used method of ventilation.

06

What researchers measure

Primary outcomes

  1. To compare lung homogeneity estimated with EIT upon commencing APRV (APRVpre) and after 30 - 60 - 120 min of APRV ventilation (APRV30, APRV60, APRV120) in patients with moderate to severe ARDS

    EIT will be measured at time APRVpre during a "low-flow maneuver" consisting of a brief switch to PC ventilation: with a flow of 4 L/min, airway pressure will be gradually increased up to 30 cmH20 in order to see how the lung changes elastically minimising resistance. EIT will also be measured after 30 min (time APRV30), 60 min (time APRV60), 120 min (time APRV120) since APRV has started.

    Time frame: 30, 60 and 120 mins

Secondary outcomes

  1. To assess recruitment at the beginning and after the end of APRV ventilation in patients with moderate-severe ARDS.

    To assess recruitment measuring change in end expiratory lung impedance (EELI) with EIT technique, and EELV with nitrogen wash-out/wash-in technique.

    Time frame: 2 hours

  2. To compare lung strain measured at APRVpre and after the end of APRV ventilation (APRVpost) in patients with moderate-severe ARDS

    Strain will be calculated at time APRVpre using the strain formula (TV/EELV)

    Time frame: 2 hours

07

Study locations

1 site
  • Guys and St Thomas NHS Foundation
    London, SE1 7EH, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — All shared data will be as a mean and not as individual

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03140579
Responsible party
Sponsor
First posted
May 4, 2017
Start date
Jun 1, 2018 (estimated)
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Aug 17, 2022

Study contacts

Luigi Camporota
principal investigator · Guy's and St Thomas' NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion