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

NCT ID: NCT05697666

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Respiratory Distress Syndrome Ventilator-Induced Lung Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

no intervention

Modulation of the depth of the neuromuscular blockade

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Saint-Brieuc

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Barbarot

Principal investigator. MD, Intensive Care Unit, Centre Hospitalier de Saint-Brieuc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas BARBAROT, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Saint Brieuc

Locations

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Centre Hospitalier de Saint Brieuc

Saint-Brieuc, Brittany Region, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 24467647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33104824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28013329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30350170 (View on PubMed)

Other Identifiers

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2023-A00165-40

Identifier Type: -

Identifier Source: org_study_id

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