IMV to Accelerate Recovery of Lung Function in Veno-venous Extracorporeal Membrane Oxygenation; Lung Rest Or Moderate Mechanical Ventilation in ECMO

NCT06006676 | Recruiting

• 1 other identifier: 256932
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility trial to inform a future multicentre randomized control trial. The investigators aim to evaluate the feasibility of a trial of near apnoeic ventilation (two breaths per minute) compared with standard ventilation (respiratory rate between 10 and 30 breaths) for patients with acute respiratory distress syndrome (ARDS) supported with veno-venous extracorporeal membrane oxygenation (V-V ECMO). Additionally, when a patient is determined as ready to wean from ECMO the investigators will explore the feasibility of two ECMO weaning strategies and explore the physiological effects on respiratory effort and gas exchange.

Conditions

ARDS

Keywords

ARDS; Critical Care; ECMO

Outcome Measures

Primary Outcomes (1)

• Number of patients receiving a ventilation strategy other than the assigned ventilation strategy over the 72 hour period following randomisation

  Number of patients receiving a ventilation strategy other than the assigned ventilation strategy over the 72 hour period following randomisation (excluding time off the ICU for imaging or surgical/interventional procedures)

  During the 72 hours following randomisation

Secondary Outcomes (5)

• Time to achieving carbon dioxide output (VCO2) natural lung > 50% of total of CO2 output

  Up to 6 months following date of randomisation

• Time to achieve a PaO2 > 30 kPa with Cilley's test (arterial oxygenation achieved after an increase in FiO2 to 1.0 with no other changes to the ventilator or ECMO settings)

  Up to 6 months following date of randomisation

• Rate of successful ECMO weaning trial

  Up to 6 months following date of randomisation

• Number of patients with non-adherence to assigned ECMO weaning strategy

  Up to 6 months following date of randomisation

• Change in total compliance of the respiratory system during a low flow pressure volume loop after 72hrs of the assigned ventilation strategy

  72 hours

Other Outcomes (11)

• Time from randomisation to ECMO decannulation

  Up to 6 months following date of randomisation

• Rate of decannulation from ECMO

  Up to 6 months following date of randomisation

• Time to achieve a successful ECMO weaning trial

  Up to 6 months following date of randomisation

Study Arms (2)

Near Apnoeic Ventilation

EXPERIMENTAL

Near Apnoeic ventilation (with a respiratory rate of 2 breaths per minute, plateau pressure of 30cmH20 and PEEP set according to the mean airway pressure being delivered during mechanical ventilation prior to randomisation) for a 72 hour period following randomisation

Other: Near Apnoeic ventilation; Other: Crossover standardised ECMO weaning trials

Standard Care

ACTIVE COMPARATOR

Standard care for patient on ECMO as per consultant with respiratory rate of 15-30, PEEP of 10cmH20 or more and Plateau pressure of 25cmH20 or less for a 72 hour period following randomisation

Other: Crossover standardised ECMO weaning trials

Interventions

Near Apnoeic ventilation OTHER

Near Apnoeic ventilation (with a respiratory rate of 2 breaths per minute, plateau pressure of 30cmH20 and PEEP set according to the mean airway pressure being delivered during mechanical ventilation prior to randomisation) for a 72 hour period following randomisation

Near Apnoeic Ventilation

Crossover standardised ECMO weaning trials OTHER

When all patients are eligible for a trial of ECMO weaning, they will have standardised ECMO weaning trials lasting up to 1 hour with 0 sweep gas flow. 1) "One-stage weaning"- sweep gas flow rate sequentially decreased to zero 2) "Two-stage weaning"- fraction of oxygen of sweep gas flow decreased to 0.21 sequentially. Then the sweep gas flow rate decreased to 0 sequentially

Near Apnoeic Ventilation; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older on the date of screening
• Acute and potentially reversible cause of ARDS
• Receiving invasive mechanical ventilation
• Requiring ECMO for severe ARDS
• Tidal volume ≥ 2.5ml/kg predicted body weight

You may not qualify if:

• Patients who meet the one or more of the following will be excluded from the trial.
• Declined consent
• \>12 hours following ECMO initiation
• Patient likely to die or for withdrawal of life sustaining therapies within 24 hours
• Use of V-A ECMO or hybrid ECMO modes
• Current pregnancy

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys & St. Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Study Officials

• Luigi Camporota, MD, PhD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Camporota, MD, PhD

CONTACT

02071883036; luigi.camporota@gstt.nhs.uk

Gill Radcliffe

CONTACT

02071888070; gill.radcliffe@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomised prospective open label trial of two ventilation strategies during V-V ECMO for ARDS with standardised crossover weaning studies

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: August 23, 2023
• Study Start: February 22, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)