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

Completed

• Conditions: Acute Respiratory Distress Syndrome; Ventilator-Induced Lung Injury
• Interventions: Other: Modulation of the depth of the neuromuscular blockade

• Registration Number: NCT05697666
• Lead Sponsor: Centre Hospitalier de Saint-Brieuc

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-28
• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-21
• Last Update Submitted: 2023-01-21
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate to severe ARDS adult patients under mechanical ventilation and neuromuscular blockade	Modulation of the depth of the neuromuscular blockade	no intervention

Primary Outcome Measures

Name	Time	Method
Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0	one day	Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the level of neuromuscular blockade (%)

Secondary Outcome Measures

Name	Time	Method
Plateau pressure	one day	Plateau pressure according to the level of neuromuscular blockade (cmH20)
Respiratory system compliance	one day	Respiratory system compliance according to the level of neuromuscular blockade (ml/cmH20)
Transpulmonary driving pressure	one day	Transpulmonary driving pressure according to the level of neuromuscular blockade (cmH20)
Pulmonary elastance	one day	Pulmonary elastance according to the level of neuromuscular blockade (cmH2O/l)
Driving pressure	one day	Driving pressure according to the level of neuromuscular blockade (cmH20)
Inspiratory transpulmonary pressure	one day	Inspiratory transpulmonary pressure according to the level of neuromuscular blockade (cmH20)
Chest wall elastance	one day	Chest wall elastance according to the level of neuromuscular blockade (cmH2O/l)
Oesophageal balloon calibration	one day	Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the oesophageal balloon calibration volume (%)

Trial Locations

Locations (1)

Centre Hospitalier de Saint Brieuc; 🇫🇷 Saint-Brieuc, Brittany, France