Some patients develop high respiratory drive during partially supported mechanical ventilation which is associated with lung and diaphragm injury and worse clinical outcome
Conditions
Interventions
Trade Name: Esmeron
Product Name: Rocuroniumbromide
Pharmaceutical Form: Solution for infusion
Sponsors
VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion if they meet all of the following criteria: - high respiratory drive, defined as tidal volume > 8ml/kg PBW on inspiratory support of 12cmH2O. - sedation level: RASS = -3 - ventilated in pressure support mode Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - recent use of NMBA (0.5 µg/kg/min) or inotropes (dobutamine >15 µg/kg/min or enoximone >25 µg/kg/min) - intracranial pressure > 20 cmH2O - past medical history of neuromuscular disorders - pregnancy - known previous anaphylactic reaction to NMBA's.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal is to investigate the feasibility and safety of prolonged (24 hours) partial neuromuscular blockade in ventilated patients with high respiratory drive in partially supported mode.;Secondary Objective: The secondary goal is to evaluate the effect of this strategy on diaphragm function, lung injury, hemodynamics and systemic inflammation compared to standard care.;Primary end point(s): Feasibility to establish and maintain lung protective ventilation for 24 hours with partial neuromuscular blockade in ventilated ICU patients with high respiratory drive in partially supported mode. 'Feasible' is define as: 'the ability to maintain tidal volume <6ml/kg PBW during the whole study protocol, without developing any directly related serious adverse events.' Therefore, the following parameters are collected: Feasibility • Percentage of breaths with tidal volume < 6ml/kg PBW • Number of patients completing the study without meeting the stopping criteria (see section 7.4.2) or serious adverse events. • Number of patients that have been withdrawn after inclusion, and reason for withdrawal. • Number of eligible patients of the total ICU population, and reason why the patient is not eligible for inclusion. • Time needed to recruit patients and collect data. Safety: • Number of directly related adverse events • Blood gas analysis: pCO2 and pH • Hemodynamic parameters: heart rate and blood pressure • Days on mechanical ventilation after the intervention • ICU mortality;Timepoint(s) of evaluation of this end point: During the study period, after 24hr and 48hr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The effect of prolonged partial neuromuscular blocking on diaphragm function and respiratory, hemodynamic and inflammatory parameters compared to standard care. Therefore, the following parameters are collected: • Respiratory and diaphragm function, assessed by measuring: - respiratory rate, tidal volume and SpO2 - work of breathing (WOB) and pressure-time product (PTP) - blood gas analysis: PaO2, PaCO2, pH • Hemodynamic parameters, such as blood pressure and heart rate. • Inflammatory parameters in blood; including TNF-a, IL-6 and IL-1ß;Timepoint(s) of evaluation of this end point: During the study period, after 24hr and 48hr | — |
Countries
Netherlands
Contacts
Public ContactL.M.A. Heunks
VUmc
Outcome results
None listed