Supported Ventilation in ARDS Patients

NCT ID: NCT02064140

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-11-30

Brief Summary

Acute respiratory distress syndrome (ARDS) is characterized by acute bilateral pulmonary infiltrates and impairment of oxygen uptake. For example, pneumonia can cause the development of ARDS. Despite modern intensive care treatment, mortality in ARDS patients remains high (40%). Invasive mechanical ventilation (MV) is the mainstay of ARDS treatment. Controlled MV is the conventional ventilation strategy to ensure lung protective ventilation (low tidal volumes) and recovery of the lungs. However, among disadvantages of controlled MV are the development of respiratory muscle atrophy (due to disuse) and the need for high dose sedatives to prevent patient-ventilator asynchrony. The use of high doses of sedatives and respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes and prolonged MV.

Besides controlled MV, a patient can be ventilated with supported ventilation. Supported MV decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics, and lowers consumption of sedatives. However potential disadvantages of supported ventilation include generation of too high tidal volumes, especially in patients with high respiratory drive. A previous study in healthy subjects has shown that titration of neuromuscular blocking agent (NMBA) can decrease activity of inspiratory muscles, while maintaining adequate ventilation. It is hypothesized that low dose NMBA may enable supported MV with adequate tidal volumes, in patients with high respiratory drive.

Conditions

Acute Respiratory Distress Syndrome; Mechanical Ventilation; Tidal Volume

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Neuromuscular blocking agent

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

Interventions

Rocuronium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age > 18 year
• informed consent
• ARDS according to the Berlin definition
• RASS -4/-5
• tidal volume > 8 ml/kg during supported ventilation
• double balloon esophageal EMG NAVA catheter

Exclusion Criteria

• recent use of muscle relaxants / NMBAs (< 3 hours)
• pre-existent neuromuscular disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases
• phrenic nerve lesions
• elevated intracranial pressure or clinical suspicion of elevated intracranial pressure (i.e. neurotrauma)
• open chest or abdomen
• pregnancy
• systolic blood pressure < 90 mm Hg / MAP < 65 mm Hg

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Nijmegen

OTHER

Sponsor Role: lead

Responsible Party

Leo Heunks

L. Heunks, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

L MA Heunks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Nijmegen

Locations

Radboud university medical center

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

MV NMBA JNLH13

Identifier Type: -

Identifier Source: org_study_id