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Clinical Trials/NCT05697666
NCT05697666
Completed
Not Applicable

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

Centre Hospitalier de Saint-Brieuc1 site in 1 country33 target enrollmentStarted: February 1, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Centre Hospitalier de Saint-Brieuc
Enrollment
33
Locations
1
Primary Endpoint
Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0

Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0

Time Frame: one day

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

Secondary Outcomes

  • Plateau pressure(one day)
  • Respiratory system compliance(one day)
  • Transpulmonary driving pressure(one day)
  • Pulmonary elastance(one day)
  • Driving pressure(one day)
  • Inspiratory transpulmonary pressure(one day)
  • Chest wall elastance(one day)
  • Oesophageal balloon calibration(one day)

Investigators

Sponsor
Centre Hospitalier de Saint-Brieuc
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nicolas Barbarot

Principal investigator. MD, Intensive Care Unit, Centre Hospitalier de Saint-Brieuc

Centre Hospitalier de Saint-Brieuc

Study Sites (1)

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