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NCT Number: NCT05697666

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Saint Brieuc

Saint-Brieuc, Brittany Region, 22000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modulation of the depth of the neuromuscular blockade

Other

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

Primary outcomes

  1. 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

  1. Inspiratory transpulmonary pressure

    Time frame: one day

    Inspiratory transpulmonary pressure according to the level of neuromuscular blockade (cmH20)

  2. Respiratory system compliance

    Time frame: one day

    Respiratory system compliance according to the level of neuromuscular blockade (ml/cmH20)

  3. Chest wall elastance

    Time frame: one day

    Chest wall elastance according to the level of neuromuscular blockade (cmH2O/l)

  4. Pulmonary elastance

    Time frame: one day

    Pulmonary elastance according to the level of neuromuscular blockade (cmH2O/l)

  5. Driving pressure

    Time frame: one day

    Driving pressure according to the level of neuromuscular blockade (cmH20)

  6. Transpulmonary driving pressure

    Time frame: one day

    Transpulmonary driving pressure according to the level of neuromuscular blockade (cmH20)

  7. Plateau pressure

    Time frame: one day

    Plateau pressure according to the level of neuromuscular blockade (cmH20)

  8. Oesophageal balloon calibration

    Time frame: one day

    Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the oesophageal balloon calibration volume (%)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Brieuc

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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