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

NCT05697666 | Completed

• 1 other identifier: 2023-A00165-40
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Keywords

Oesophageal pressure; Transpulmonary pressure; Train of four; Neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• 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 (%)

  one day

Secondary Outcomes (8)

• Inspiratory transpulmonary pressure

  one day

• Respiratory system compliance

  one day

• Chest wall elastance

  one day

• Pulmonary elastance

  one day

• Driving pressure

  one day

Study Arms (1)

Moderate to severe ARDS adult patients under mechanical ventilation and neuromuscular blockade

no intervention

Other: Modulation of the depth of the neuromuscular blockade

Interventions

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

Moderate to severe ARDS adult patients under mechanical ventilation and neuromuscular blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population includes mainly pulmonary ARDS with a predominance of SARS-CoV2 pneumonia

You may qualify if:

• 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

You may not qualify if:

• contraindication of oesophageal catheter

Sponsors & Collaborators

• Centre Hospitalier de Saint-Brieuc: lead

Study Sites (1)

Centre Hospitalier de Saint Brieuc

Saint-Brieuc, Brittany Region, 22000, France

Location

Related Publications (4)

• Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.

  PMID: 24467647 BACKGROUND

• Alhazzani W, Belley-Cote E, Moller MH, Angus DC, Papazian L, Arabi YM, Citerio G, Connolly B, Denehy L, Fox-Robichaud A, Hough CL, Laake JH, Machado FR, Ostermann M, Piraino T, Sharif S, Szczeklik W, Young PJ, Gouskos A, Kiedrowski K, Burns KEA. Neuromuscular blockade in patients with ARDS: a rapid practice guideline. Intensive Care Med. 2020 Nov;46(11):1977-1986. doi: 10.1007/s00134-020-06227-8. Epub 2020 Oct 26.

  PMID: 33104824 BACKGROUND

• Guervilly C, Bisbal M, Forel JM, Mechati M, Lehingue S, Bourenne J, Perrin G, Rambaud R, Adda M, Hraiech S, Marchi E, Roch A, Gainnier M, Papazian L. Effects of neuromuscular blockers on transpulmonary pressures in moderate to severe acute respiratory distress syndrome. Intensive Care Med. 2017 Mar;43(3):408-418. doi: 10.1007/s00134-016-4653-4. Epub 2016 Dec 24.

  PMID: 28013329 BACKGROUND

• Baedorf Kassis E, Train S, MacNeil B, Loring SH, Talmor D. Monitoring of neuromuscular blockade: a comparison of train-of-four and the Campbell diagram. Intensive Care Med. 2018 Dec;44(12):2305-2306. doi: 10.1007/s00134-018-5420-5. Epub 2018 Oct 22. No abstract available.

  PMID: 30350170 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Nicolas BARBAROT, MD

  Centre Hospitalier Saint Brieuc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. MD, Intensive Care Unit, Centre Hospitalier de Saint-Brieuc

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: February 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 28, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)