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Impact of the Depth of Neuromuscular Blockade on Respiratory Mechanics in Moderate to Severe ARDS Patients

The Depth of Neuromuscular Blockade is Not Related to Expiratory Transpulmonary Pressure and Respiratory Mechanics in Moderate to Severe ARDS Patients. A Prospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05697666
Enrollment
33
Registered
2023-01-26
Start date
2020-02-01
Completion date
2022-02-28
Last updated
2023-01-26

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

Conditions

Acute Respiratory Distress Syndrome, Ventilator-Induced Lung Injury

Keywords

Oesophageal pressure, Transpulmonary pressure, Train of four, Neuromuscular blockade

Brief summary

Neuromuscular blockade (NMB) is proposed in patients with moderate to severe acute respiratory distress syndrome (ARDS). The supposed benefit of these muscle relaxants could be partly linked to their effects on respiratory mechanics by reducing ventilator induced lung injuries (VILI), especially the so called atelectrauma. Although its monitoring is recommended in clinical practice, data about the depth of NMB necessary for an effective relaxation of the thoracic and diaphragmatic muscles and, therefore, the reduction of the chest wall elastance, are scarce. The investigators hypothesised that complete versus partial NMB can modify respiratory mechanics and its partitioning.

Detailed description

The investigators conducted a prospective study to compare the respiratory mechanics of patients with moderate to severe ARDS according to the NMB depth, using an oesophageal pressure catheter (NutriVent®, Sidam) for transpulmonary pressure (PL) assessment, and facial train of four (TOF) for neuromuscular blockade monitoring. The oesophageal balloon was calibrated according to the method recently described to estimate the individual target volume which is assumed to be more adequate. Each patient was analysed at two different times: deep NMB (TOF = 0) and intermediate to light NMB (TOF \> 0). The mechanical ventilation parameters were identical for these two measurements. The primary endpoint was the proportion of patients with expiratory transpulmonary pressure (PLexp) greater than or equal to 0 according to the NMB level, in order to assess the risk of region-dependent atelectasis and alveolar opening/closing injury (atelectrauma). Secondary endpoints included: the impact of the depth of NMB on other partition parameters of respiratory mechanics, and the variability of results according to the type of oesophageal balloon calibration.

Interventions

OTHERModulation of the depth of the neuromuscular blockade

Analysis of the respiratory mechanics at two times: * Facial train of four = 0, indicating a deep neuromuscular blockade * Facial train of four \> 0, indicating a intermediate to light neuromuscular blockade

Sponsors

Centre Hospitalier de Saint-Brieuc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Moderate to severe ARDS patients with PaO2/FiO2 ratio \< 150 mmHg * Mechanical ventilation, deep sedation and neuromuscular blockade with continuous infusion of cisatracurium for more than 24 hours * Presence of an oesophageal catheter * Written informed consent

Exclusion criteria

* contraindication of oesophageal catheter

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0one dayProportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the level of neuromuscular blockade (%)

Secondary

MeasureTime frameDescription
Respiratory system complianceone dayRespiratory system compliance according to the level of neuromuscular blockade (ml/cmH20)
Chest wall elastanceone dayChest wall elastance according to the level of neuromuscular blockade (cmH2O/l)
Pulmonary elastanceone dayPulmonary elastance according to the level of neuromuscular blockade (cmH2O/l)
Inspiratory transpulmonary pressureone dayInspiratory transpulmonary pressure according to the level of neuromuscular blockade (cmH20)
Transpulmonary driving pressureone dayTranspulmonary driving pressure according to the level of neuromuscular blockade (cmH20)
Plateau pressureone dayPlateau pressure according to the level of neuromuscular blockade (cmH20)
Oesophageal balloon calibrationone dayProportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the oesophageal balloon calibration volume (%)
Driving pressureone dayDriving pressure according to the level of neuromuscular blockade (cmH20)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026