An observational study in Acute Respiratory Distress Syndrome and Ventilator-Induced Lung Injury, sponsored by Centre Hospitalier de Saint-Brieuc. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Centre Hospitalier de Saint-Brieuc · Observational
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.
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Centre Hospitalier de Saint-Brieuc is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population includes mainly pulmonary ARDS with a predominance of SARS-CoV2 pneumonia
Exclusion Criteria:
no intervention
Other: Modulation 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
Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0
Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the level of neuromuscular blockade (%)
Time frame: one day
Inspiratory transpulmonary pressure
Inspiratory transpulmonary pressure according to the level of neuromuscular blockade (cmH20)
Time frame: one day
Respiratory system compliance
Respiratory system compliance according to the level of neuromuscular blockade (ml/cmH20)
Time frame: one day
Chest wall elastance
Chest wall elastance according to the level of neuromuscular blockade (cmH2O/l)
Time frame: one day
Pulmonary elastance
Pulmonary elastance according to the level of neuromuscular blockade (cmH2O/l)
Time frame: one day
Driving pressure
Driving pressure according to the level of neuromuscular blockade (cmH20)
Time frame: one day
Transpulmonary driving pressure
Transpulmonary driving pressure according to the level of neuromuscular blockade (cmH20)
Time frame: one day
Plateau pressure
Plateau pressure according to the level of neuromuscular blockade (cmH20)
Time frame: one day
Oesophageal balloon calibration
Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the oesophageal balloon calibration volume (%)
Time frame: one day
Plan to share: No
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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