Testing of a machine which monitors ventilator settings and advises the caregiver to try and improve breathing in patients with respiratory failure (ARDS)

Not Applicable

Completed

• Conditions: Acute respiratory distress syndrome; Respiratory

• Registration Number: ISRCTN51550701
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-03
• Study Completion: 2021-09-30
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Invasive mechanical ventilation
2. A known clinical insult with new worsening respiratory symptoms
3. Chest radiograph with bilateral infiltrates consistent with evidence of pulmonary oedema but not fully explained by cardiac failure
4. Hypoxaemia as defined by PaO2/FiO2 of = 300mmHg (or =40kPa) (pre-ECMO PaO2/FiO2 will be used should patient be placed on extracorporeal support)

Exclusion Criteria

1. Aged <18 years
2. The absence of an arterial catheter for blood sampling at study start
3. Consent declined
4. Over 7 days of mechanical ventilation
5. Treatment withdrawal imminent within 24 h
6. DNAR (Do Not Attempt Resuscitation) order in place
7. Severe chronic respiratory disease requiring domiciliary ventilation and/or home oxygen therapy (except for sleep disordered breathing)
8. Veno-ArterialVA ECMO ECMO
9. Head trauma or other conditions where intra-cranial pressure may be elevated and tight regulation of arterial CO2 level is paramount

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Driving pressure will be measured once a day, using end inspiratory and expiratory pauses Respiratory pressures at the end of inspiratory (Pplat) and expiratory (PEEP) pauses are known to approximate average pressure in the alveoli at these points, such that their difference, Pplat-PEEP, is the correct measure of driving pressure applied to the lungs. This measurement will only be performed in breaths where no spontaneous breathing activity occurs. In addition to the measurement of driving pressure performed, surrogate measurements of driving pressure will be obtained continuously by approximating Pplat with peak inspiratory pressure (Ppeak), and PEEP with PEEP values set on the ventilator (PEEPset).