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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05697666
• Other study ID #: 2023-A00165-40
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2023
• Source: Centre Hospitalier de Saint-Brieuc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 28, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Ventilator-Induced Lung Injury

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

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint Brieuc	Saint-Brieuc	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Saint-Brieuc

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inspiratory transpulmonary pressure	Inspiratory transpulmonary pressure according to the level of neuromuscular blockade (cmH20)	one day
Secondary	Respiratory system compliance	Respiratory system compliance according to the level of neuromuscular blockade (ml/cmH20)	one day
Secondary	Chest wall elastance	Chest wall elastance according to the level of neuromuscular blockade (cmH2O/l)	one day
Secondary	Pulmonary elastance	Pulmonary elastance according to the level of neuromuscular blockade (cmH2O/l)	one day
Secondary	Driving pressure	Driving pressure according to the level of neuromuscular blockade (cmH20)	one day
Secondary	Transpulmonary driving pressure	Transpulmonary driving pressure according to the level of neuromuscular blockade (cmH20)	one day
Secondary	Plateau pressure	Plateau pressure according to the level of neuromuscular blockade (cmH20)	one day
Secondary	Oesophageal balloon calibration	Proportion of patients with expiratory transpulmonary pressure greater than or equal to 0 according to the oesophageal balloon calibration volume (%)	one day