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
Sponsor study identifier
observational
33
1 country
1
Study Start
February 1, 2020
Actual (reported)Primary Completion
February 1, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2020
Actual (reported)February 1, 2022
Actual (reported)February 28, 2022
Actual (reported)January 12, 2023
Actual (reported)January 26, 2023
Actual (reported)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
Inspiratory transpulmonary pressure
one day
Respiratory system compliance
one day
Chest wall elastance
one day
Pulmonary elastance
one day
Driving pressure
one day
no intervention
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
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The population includes mainly pulmonary ARDS with a predominance of SARS-CoV2 pneumonia
Centre Hospitalier de Saint Brieuc
Saint-Brieuc, Brittany Region, 22000, France
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.
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.
Nicolas BARBAROT, MD
Centre Hospitalier Saint Brieuc
33 participants (actual enrollment reported by the registry).
First Submitted
January 12, 2023
First Posted
January 26, 2023
Study Start
February 1, 2020
Actual (reported)Pulmonary and Ventilatory Effects of Bed Verticalization in Patients With Acute Respiratory Distress Syndrome
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
February 1, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
January 26, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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