Partial neuromuscular blockade to facilitate lung and diaphragm protective mechanical ventilation in ICU patients: A randomized controlled pilot study.

Partial neuromuscular blockade to facilitate lung and diaphragm protective mechanical ventilation in ICU patients: A randomized controlled pilot study. - Partial neuromuscular blockade for lung protective mechanical ventilation

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50261

Enrollment

Registered

2018-06-12

Start date

2018-09-14

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Middenrif / longfunctie Diaphragm dysfunction lung injury due to mechanical ventilation

Interventions

Intervention group: titration until tidal volume of 6ml/kg predicted body weight is reached, followed by continuous administration of partial neuromuscular blockade with rocuronium bromide for 24 hr

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - high respiratory drive, defined as tidal volume > 8ml/kg PBW on inspiratory support of 12cmH2O. - sedation level: RASS

Exclusion criteria

Exclusion criteria: - 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
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	—

Secondary

Measure	Time frame
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: o respiratory rate, tidal volume and SpO2 o work of breathing (WOB) and pressure-time product (PTP) o blood gas analysis: PaO2, PaCO2, pH • Hemodynamic parameters, assessed by measuring clinical parameters such as blood pressure and heart rate. • Inflammatory parameters in blood; including TNF-a, IL-6 and IL-1β 7.1.3 Other study parameters In addition, we recorded the following data: • Sex, age and body mass index (BMI) • Reason for admission and co-morbidity • Amount of days on controlled mechanical ventilation before study period • RASS, dose of sedatives and analgesics • Ventilator settings: FiO2, PEEP, pressure support level and PaO2/FiO2 ratio • If EAdi catheter in situ: EAdi signal and neuromuscular efficiency (NME)	—

Measure

Time frame

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: o respiratory rate, tidal volume and SpO2 o work of breathing (WOB) and pressure-time product (PTP) o blood gas analysis: PaO2, PaCO2, pH • Hemodynamic parameters, assessed by measuring clinical parameters such as blood pressure and heart rate. • Inflammatory parameters in blood; including TNF-a, IL-6 and IL-1β 7.1.3 Other study parameters In addition, we recorded the following data: • Sex, age and body mass index (BMI) • Reason for admission and co-morbidity • Amount of days on controlled mechanical ventilation before study period • RASS, dose of sedatives and analgesics • Ventilator settings: FiO2, PEEP, pressure support level and PaO2/FiO2 ratio • If EAdi catheter in situ: EAdi signal and neuromuscular efficiency (NME)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)