Closed Loop Mechanical Ventilation and ECMO

NCT04925518 | Completed

• 1 other identifier: ECMO - IV
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mechanical ventilation and ECMO are both technologies interacting on gas exchange. Nevertheless, besides a consensus paper, no evidence-based guidelines regarding protective lung ventilation on ECMO exist to date. Mechanical Ventilation with Intellivent-ASV, an algorithm driven, closed loop system, provides an opportunity to standardize ventilation on ECMO. We propose and validate lung protective ventilation with a closed loop ventilation mode in patients with ECMO.

Conditions

Acute Respiratory Distress Syndrome; Cardiogenic Shock

Keywords

ECMO; ECLS; Mechanical Ventilation; Lung Protective Ventilation; Closed Loop Ventilation

Outcome Measures

Primary Outcomes (6)

• Change in Tidal Volumes

  Assessment of tidal volumes over the initial 72 hours post switch to closed loop mechanical ventilation

  Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

• Change in Driving Pressure

  Assessment of Driving Pressure over the initial 72 hours post switch to closed loop mechanical ventilation

  Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

• Change in Peak Pressure

  Assessment of Peak Pressure over the initial 72 hours post switch to closed loop mechanical ventilation

  Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

• Change in Mechanical Power

  Assessment of Mechanical Power over the initial 72 hours post switch to closed loop mechanical ventilation

  Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

• Change in Partial Pressure of Arterial Oxygen

  Assessment of Partial Pressure of Arterial Oxygen over the initial 72 hours post switch to closed loop mechanical ventilation

  Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

• Change in Partial Pressure of Arterial CO2

  Assessment of Partial Pressure of Arterial CO2 over the initial 72 hours post switch to closed loop mechanical ventilation

  Mixed Model Assessment at baseline (conventional mode), 0 (switch to closed loop), 8, 16, 24, 48 and 72 hours

Study Arms (2)

Conventional Ventilation Mode

ACTIVE COMPARATOR

Patients mechanically ventilated with a conventional mechanical ventilation mode until steady state is achieved for several hours.

Device: Conventional Mechanical Ventilation

Closed Loop Ventilation Mode

EXPERIMENTAL

Once steady state on the conventional mechanical ventilation mode is achieved for several hours, switch to closed loop ventilation mode for the remainder of the study period.

Device: Closed Loop Mechanical Ventilation

Interventions

Closed Loop Mechanical Ventilation DEVICE

Closed loop ventilation mode (Intellivent-ASV+®). Intellivent-ASV+® was initiated by activating the controllers for minute volume, PEEP (range 5 to 18 cmH2O) and fraction of inspired oxygen (FiO2) (range 21 to 100 %). The target shift ranges for CO2-management were set between -2.5 and +2.5 kPa, and for O2-management between -2 and +2 %.

Also known as: Intellivent-ASV+®

Closed Loop Ventilation Mode

Conventional Mechanical Ventilation DEVICE

Mechanical ventilation with a conventional mode, usually either biphasic positive airway pressure ventilation (DuoPAP®) or adaptive support ventilation (ASV®)

Also known as: DuoPaP/ ASV

Conventional Ventilation Mode

Eligibility Criteria

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

You may qualify if:

• Mechanical Ventilation and ECMO
• Refractory Acute Respiratory Distress Syndrome or Refractory Cardiogenic Shock

You may not qualify if:

• Contraindications for ECMO
• Contraindications for Closed Loop Ventilation
• Rejection of participation

Sponsors & Collaborators

• University of Zurich: lead

Related Publications (7)

• ELSO Guidelines for Cardiopulmonary Extracorporeal Life Support Extracorporeal Life Support Organization, Version 1.4 August 2017 Ann Arbor, MI, USA

  BACKGROUND

• Richard C, Argaud L, Blet A, Boulain T, Contentin L, Dechartres A, Dejode JM, Donetti L, Fartoukh M, Fletcher D, Kuteifan K, Lasocki S, Liet JM, Lukaszewicz AC, Mal H, Maury E, Osman D, Outin H, Richard JC, Schneider F, Tamion F. Extracorporeal life support for patients with acute respiratory distress syndrome: report of a Consensus Conference. Ann Intensive Care. 2014 May 24;4:15. doi: 10.1186/2110-5820-4-15. eCollection 2014.

  PMID: 24936342 BACKGROUND

• Pesenti A, Carlesso E, Langer T, Mauri T. Ventilation during extracorporeal support : Why and how. Med Klin Intensivmed Notfmed. 2018 Feb;113(Suppl 1):26-30. doi: 10.1007/s00063-017-0384-8. Epub 2017 Nov 28.

  PMID: 29184987 BACKGROUND

• Serpa Neto A, Schmidt M, Azevedo LC, Bein T, Brochard L, Beutel G, Combes A, Costa EL, Hodgson C, Lindskov C, Lubnow M, Lueck C, Michaels AJ, Paiva JA, Park M, Pesenti A, Pham T, Quintel M, Marco Ranieri V, Ried M, Roncon-Albuquerque R Jr, Slutsky AS, Takeda S, Terragni PP, Vejen M, Weber-Carstens S, Welte T, Gama de Abreu M, Pelosi P, Schultz MJ; ReVA Research Network and the PROVE Network Investigators. Associations between ventilator settings during extracorporeal membrane oxygenation for refractory hypoxemia and outcome in patients with acute respiratory distress syndrome: a pooled individual patient data analysis : Mechanical ventilation during ECMO. Intensive Care Med. 2016 Nov;42(11):1672-1684. doi: 10.1007/s00134-016-4507-0. Epub 2016 Sep 1.

  PMID: 27586996 BACKGROUND

• Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

  PMID: 25693014 BACKGROUND

• Arnal JM, Wysocki M, Novotni D, Demory D, Lopez R, Donati S, Granier I, Corno G, Durand-Gasselin J. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV(R)) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study. Intensive Care Med. 2012 May;38(5):781-7. doi: 10.1007/s00134-012-2548-6. Epub 2012 Mar 30.

  PMID: 22460854 BACKGROUND

• Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.

  PMID: 24025234 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Marco Maggiorini

  Medizinische Intensivstation D-HOER 27, UniversitatsSpital Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are initially mechanically ventilated with a conventional mechanical ventilation mode after ECMO installation, once steady state on the conventional mode is achieved for several hours, switch to the closed loop ventilation mode.

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 14, 2021
• Study Start: March 6, 2016
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share