Partial Neuromuscular Blockade for Lung Protective Mechanical Ventilation

May 19, 2020 updated by: Diana Jansen, Amsterdam UMC, location VUmc

Partial Neuromuscular Blockade to Facilitate Lung and Diaphragm Protective Mechanical Ventilation in Intensive Care Unit Patients: a Randomized Controlled Pilot Study

Controlled mechanical ventilation may lead to the development of diaphragm muscle atrophy, which is associated with weakness and adverse clinical outcome. Therefore, it seems reasonable to switch to partially supported ventilator modes as soon as possible. However, in patients with high respiratory drive, the application of partially supported modes may result in high lung distending pressures and diaphragm injury.

Recently, the investigators published a study that demonstrated that a low dose of neuromuscular blocking agents (NMBA) facilitates lung-protective ventilation and maintains diaphragm activity in intensive care unit (ICU) patients. That study was conducted in a small (N=10), selected group of patients and partial neuromuscular blockade was applied for only 2 hours (proof-of-concept study). Therefore, further research has to be done before this strategy can be applied in clinical practice.

The primary goal is to investigate the feasibility and safety of prolonged (24 hours) partial neuromuscular blockade in patients with high respiratory drive in partially supported mode. The secondary goals are to evaluate the effect of this strategy diaphragm function, lung injury, hemodynamics and systemic inflammation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • VUmc
        • Contact:
          • L.M.A. Heunks, Prof.dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • high respiratory drive, defined as tidal volume > 8ml/kg PBW on inspiratory support of 12 cmH2O.
  • sedation level: richmond agitation-sedation scale (RASS) ≤ -3
  • ventilated in pressure support mode

Exclusion Criteria:

  • recent use of NMBA (< 2 hrs)
  • arterial pH < 7.25
  • hemodynamic instability, i.e. high dose vasopressors (>0.5 μg/kg/min) or inotropes (dobutamine >15 μg/kg/min or enoximone >25 μg/kg/min)
  • intracranial pressure > 20 cmH2O
  • past medical history of neuromuscular disorders
  • known pregnancy
  • known previous anaphylactic reaction to NMBA's.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Standard of care
Experimental: Rocuronium
Titration of rocuronium bromide until tidal volume of 6ml/kg predicted body weight (PBW) is reached
Drug: Rocuronium Bromide
Titration with rocuronium bromide until tidal volume 6ml/kg PBW
Other Names:
  • Esmeron

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The percentage of breaths with tidal volume 6ml/kg predicted body weight (PBW)
Time Frame: At five time points of 1hr during the first 24hrs of the study period
During the study period we measure at five time points of 1 hour (T0, T1, T5, T12, T24) all breaths and determine the percentage of breaths with a tidal volume of 6ml/kg PBW.
At five time points of 1hr during the first 24hrs of the study period
Incidence of directly related serious adverse events
Time Frame: During the 48hrs study period

A serious adverse event is any untoward medical occurence or effect that:

  • results in death
  • is life threatening
  • requires prolongation of existing inpatients' hospitalization
  • results in persistent or significatn disability or incapacity
  • is a new event of the trial medication to affect the safety of the subjects, such as adverse events which are not already were described
During the 48hrs study period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients completing the study without meeting the stopping criteria
Time Frame: At four time points during the first 24hrs of the study period

After each time point (T0, T1, T5 and T12) we screen if the patient meets one of the stopping criteria, defined as:

  • potential of hydrogen (pH) < 7.20
  • heart rate > 100 beats per minute or an increase of > 20% from baseline for more than 20 minutes
  • increase in mean arterial blood pressure of > 20% for more than 20 minutes
At four time points during the first 24hrs of the study period
Effect on partial carbon dioxide (pCO2)
Time Frame: During the 48hrs study period

At three time points (T0, T24, T48) during the study period we will collect a blood sample from the arterial catheter, to measure the effect of prolonged NMB administration on pCO2 (in kPa), in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups
During the 48hrs study period
Effect on pH
Time Frame: During the 48hrs study period

At three time points (T0, T24, T48) during the study period we will collect a blood sample from the arterial catheter, to measure the effect of prolonged NMB administration on pH, in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the 48hrs study period
Effect on heart rate
Time Frame: During the 48hrs study period

During the study period we will collect at six time points (T0, T1, T5, T12, T24 and T48) the heart rate (in beats per minute), in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the 48hrs study period
Effect on blood pressure
Time Frame: During the 48hrs study period

During the study period we will collect at six time points (T0, T1, T5, T12, T24 and T48) the blood pressure (millimetre(s) of mercury (mmHg)), in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the 48hrs study period
Effect on respiratory rate
Time Frame: During the 48hrs study period

During the study period we will collect at six time points (T0, T1, T5, T12, T24 and T48) the respiratory rate (in breaths per minute) in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the 48hrs study period
Effect on peripheral capillary oxygen saturation (SpO2)
Time Frame: During the 48hrs study period

During the study period we will collect at six time points (T0, T1, T5, T12, T24 and T48) the SpO2 (%) in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the 48hrs study period
Effect on partial oxygen pressure (pO2)
Time Frame: During the 48hrs study period

At three time points (T0, T24, T48) during the study period we will collect a blood sample from the arterial catheter, to measure the effect of prolonged NMB administration on pO2 (in kPa), in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the 48hrs study period
Effect on work of breathing (WOB)
Time Frame: During the first 24hrs of the study period

During the study period we will collect at five time points (T0, T1, T5, T12 and T24) the WOB (in Joule) in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the first 24hrs of the study period
Effect on pressure time product (PTP)
Time Frame: During the first 24hrs of the study period

During the study period we will collect at five time points (T0, T1, T5, T12 and T24) the PTP (in cmH2O per second) in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the first 24hrs of the study period
Effect on tumor necrosis factor (TNF)-alfa
Time Frame: During the first 24hrs of the study period

At three time points (T0, T24, T48) during the study period we will collect a blood sample from the arterial catheter, to measure the effect of prolonged NMB administration on TNF-alfa concentration (in pg/ml), in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the first 24hrs of the study period
Effect on interleukin(IL)-6 and IL-8
Time Frame: During the first 24hrs of the study period

At three time points (T0, T24, T48) during the study period we will collect a blood sample from the arterial catheter, to measure the effect of prolonged NMB administration on IL-6 and IL-8 concentration (in pg/ml), in order to:

  • determine if there were differences between the start and end of the study period
  • investigate if there were differences between both study groups.
During the first 24hrs of the study period
Amount of days on mechanical ventilation
Time Frame: Until 30 days after the end of the study period
After 30 days we will investigate if there were differences between both groups in the duration of mechanical ventilation.
Until 30 days after the end of the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL65192.029.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

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