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

Sponsor
Centre Hospitalier de Saint-Brieuc (Other)
Overall Status
Completed
CT.gov ID
NCT05697666
Collaborator
(none)
33
1
24.9
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Modulation of the depth of the neuromuscular blockade

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
Actual Enrollment :
33 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Moderate to severe ARDS adult patients under mechanical ventilation and neuromuscular blockade

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Inspiratory transpulmonary pressure [one day]

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

  2. Respiratory system compliance [one day]

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

  3. Chest wall elastance [one day]

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

  4. Pulmonary elastance [one day]

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

  5. Driving pressure [one day]

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

  6. Transpulmonary driving pressure [one day]

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

  7. Plateau pressure [one day]

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

  8. 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 (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de Saint Brieuc Saint-Brieuc Brittany France 22000

Sponsors and Collaborators

  • Centre Hospitalier de Saint-Brieuc

Investigators

  • Principal Investigator: Nicolas BARBAROT, MD, Centre Hospitalier Saint Brieuc

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nicolas Barbarot, Principal investigator. MD, Intensive Care Unit, Centre Hospitalier de Saint-Brieuc, Centre Hospitalier de Saint-Brieuc
ClinicalTrials.gov Identifier:
NCT05697666
Other Study ID Numbers:
  • 2023-A00165-40
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 26, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nicolas Barbarot, Principal investigator. MD, Intensive Care Unit, Centre Hospitalier de Saint-Brieuc, Centre Hospitalier de Saint-Brieuc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2023