Supported Ventilation in ARDS Patients

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Reducing High Respiratory Drive to Facilitate Supported Ventilation in ARDS Patients: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064140
• Other study ID #: MV NMBA JNLH13
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: December 1, 2014
• Start date: February 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Mechanical Ventilation
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Tidal Volume

Intervention

Drug:
• Rocuronium

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Respiratory rate	A secondary outcome measure is the respiratory rate after titration NMBA during different ventilatory modes.	Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA	No
Secondary	Diaphragm electrical activity	A secondary outcome measure is the root-mean-square of the diaphragm electrical activity after titration NMBA during different ventilatory modes.	Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.	No
Secondary	Transpulmonary pressure	Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first 2 minutes after titration NMBA during different ventilatory modes.	Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.	No
Secondary	Transdiaphragmatic pressure	Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the first two minutes after titration NMBA during different ventilatory modes.	Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.	No
Secondary	Neuroventilatory efficiency	A secondary outcome measure is the neuroventilatory efficiency (i.e. the ratio of diaphragm electrical activity and tidal volume) after titration NMBA during different ventilatory modes.	Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.	No
Secondary	Neuromechanical efficiency	A secondary outcome measure is the neuromechanical efficiency (i.e. the ratio of diaphragm electrical activity and transdiaphragmatic pressure) of the diaphragm after titration NMBA during different ventilatory modes.	Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.	No
Secondary	Patient-ventilator contribution to breathing	A secondary outcome measure is the patient-ventilator contribution to breathing (i.e. ratio of: the ratio of tidal volume and diaphragm electrical activity without assist, and the ratio of tidal volume and diaphragm electrical acticity with assist) during and after titration of NMBA.	During titration of NMBA (each three minutes) and during PS and NAVA after titration NMBA	No
Secondary	Oxygenation index	A secondary parameter is the oxygenation index which is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen.	Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.	Yes
Secondary	Carbon dioxide tension in arterial blood (PaCO2)	A secondary parameter is the carbon dioxide tension in arterial blood.	Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.	Yes
Secondary	pH of arterial blood	A secondary parameter is the pH of arterial blood.	Before start of the study; before titration of NMBA during different ventilatory modes; after titration of NMBA; after an hour for each ventilatory mode.	Yes
Secondary	Patient-ventilator interaction	Patient-ventilator interaction is evaluated using the NeuroSync index during different ventilatory modes.	Artefact-free period in the first 15 minutes during different ventilatory modes after titration of NMBA.	No