Partial Neuromuscular Blockade in Acute Respiratory Distress Syndrome

Respiratory Insufficiency Clinical Trial

— PNEUMA  

Official title:

Partial Neuromuscular Blockade in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04524585
• Other study ID #: 19-5975
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PNEUMA is a preliminary safety and feasibility trial of a novel approach to the titration of neuromuscular blockade (NMB) to safe spontaneous breathing in patients with severe acute respiratory distress syndrome (ARDS) supported with veno-venous extracorporeal membrane oxygenation (VV-ECMO).

Description:

Controlling respiratory effort in patients with ARDS can be challenging, as they often exhibit a very high respiratory drive despite receiving high doses of sedatives. Consequently, these patients usually receive full neuromuscular blockade, with the goal to avoid such injurious respiratory efforts. Unfortunately, full neuromuscular blockade is not without complications. To address this issue, the use of partial neuromuscular blockade has been proposed as a strategy to maintain respiratory muscle activity while providing lung protective ventilation.

The objective of this study is to demonstrate the safety and feasibility of safe spontaneous breathing using partial NMB in severe ARDS patients supported on VV-ECMO.

An esophageal balloon and a catheter will be placed. Once adequate sedation has been ensured, small boluses of cisatracurium will be administered. Then, an infusion of cisatracurium will be started to maintain spontaneous breathing at esophageal pressure swings (Pes) of 3-10 cm H2O or selected diaphragm electrical activity (Edi) targets. After establishing a sedation and NMB dosing regimen at which safe spontaneous breathing is achieved, we will document whether these targets can be maintained over a 24-hour period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Potentially injurious respiratory efforts as defined by esophageal pressure swings or occlusion pressure swing AND Riker Sedation-Agitation Scale (SAS) =2 (if the clinical team has elected to sedate to that depth).

2. The medical team has undertaken a trial of discontinuing neuromuscular blockade and determined that the patient requires reinstitution of neuromuscular blockade to ensure toleration of ECMO and they are willing for the patient undergo a trial of partial neuromuscular blockade

3. The patient is receiving neuromuscular blockade with no plan to discontinue neuromuscular blockade until the next day and the medical team is willing for the patient to undergo a trial of partial neuromuscular blockade

Exclusion Criteria:

1. Decannulation from VV-ECMO is anticipated within 24 hours

2. Contraindication to esophageal catheterization

3. Contraindication to neuromuscular blockade (allergy, history of malignant hyperthermia)

4. Patient has a condition deemed by the medical team to require complete NMB

Related Conditions & MeSH terms

• Acute Lung Injury
• Extracorporeal Membrane Oxygenation Complication
• Neuromuscular Blockade
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Drug:
• Neuromuscular blockade
Cisatracurium will be infused to achieve esophageal pressure targets and maintain a Riker Sedation-Agitation Scale (SAS) score of 1-2. Additional boluses of cisatracurium will be delivered as required and adjustment of continuous infusion rate. After establishing a sedation and NMB strategy at which safe spontaneous breathing is achieved, we will seek to determine whether these targets can be maintained over a 24-hour period.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients achieving and maintaining targeted esophageal pressure swings		Assessed after achievement of Pes targets for 24 hours
Secondary	Rates of serious adverse events		Assessed maintenance 24 hours phase