Supported Ventilation in ARDS Patients

NCT02064140 | Completed

• 1 other identifier: MV NMBA JNLH13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

ARDS; Mechanical Ventilation; Tidal volume; NMBA

Outcome Measures

Primary Outcomes (1)

• Feasibility of titrating tidal volume < 6 ml/kg

  The feasibility of titrating tidal volume in ARDS patients below 6 ml/kg using NMBA is evaluated in every patient. The outcome measure is dichotomic (yes/no).

  Within 5 minutes after titration of NMBA

Secondary Outcomes (11)

• Respiratory rate

  Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA

• Diaphragm electrical activity

  Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

• Transpulmonary pressure

  Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

• Transdiaphragmatic pressure

  Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

• Neuroventilatory efficiency

  Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.

Study Arms (1)

Neuromuscular blocking agent

EXPERIMENTAL

Drug: Rocuronium

Interventions

Rocuronium DRUG

Neuromuscular blocking agent

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Nijmegen: lead

Study Sites (1)

Radboud university medical center

Nijmegen, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• L MA Heunks, MD, PhD

  University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: L. Heunks, MD PhD

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

NL (1)