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Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)

Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01573715
Enrollment
40
Registered
2012-04-09
Start date
2012-04-30
Completion date
2014-12-31
Last updated
2014-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Brief summary

Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows: * reduction of the consumption of oxygen linked to ventilatory workload; * increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy; * anti-inflammatory effect contributing to a reduction in pulmonary inflammation and improvement in oxygenation, * reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator. The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.

Interventions

DRUGNIMBEX
OTHERWITHOUT NIMBEX

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Early (\< 48H) Severe ARDS: PaO2 / FiO2 ratio \< 150 with PEEP \>= 5 cmH20

Exclusion criteria

Age \< 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube

Design outcomes

Primary

MeasureTime frameDescription
Delta TPP27 monthsReduction of Delta TPP at 48 hr in the NMBA group by comparison with the control group in ARDS patients

Countries

France

Contacts

Primary Contactmagali BISBAL
magali.bisbal@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026