The study Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters) Neuromuscular blocking agents (NMBAs) are drug capable of inducing a complete paralysis of the muscle. Their use is frequent in the intensive care unit (ICU). Most of the time it is used as a single infusion to facilitate endotracheal intubation, but in the ICU the use of continuous infusion is common in several pathologies: acute distress respiratory syndrome, post-cardiac arrest survivor under hypothermia to prevent shivering, abdominal compartment syndrome, severe traumatic brain injury with uncontrolled intra-cranial pressure and severe asthma among others.
A monitoring of the dose of NMBAs is recommended to guide the depth of paralysis and to guide recovery, but in the ICU, the interest of such a monitoring during continuous infusion is unclear and the level of evidence is low.
The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective we will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigators will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints.
Condition or disease | Intervention/treatment |
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Critical Care Mechanical Ventilation Neuromuscular Blockade | Drug: Neuromuscular Blocking Agents |
Neuromuscular blocking agents (NMBAs) are usually administered during anesthesia for endotracheal tube placement or surgical interventions. But their use is also common in the medical intensive care unit (ICU) (1, 2). Together with sedation and analgesia, they are mainly used in continuous infusion in Acute Respiratory Distress Syndrom (ARDS) (3, 4), but also in post-cardiac arrest survivor under hypothermia to prevent shivering (5), in abdominal compartment syndrome (6), in severe traumatic brain injury with uncontrolled intra-cranial pressure (7) and severe asthma among others.
A monitoring of the treatment is recommended (8) and several monitoring techniques exists: qualitative clinical monitoring is known to be inefficient, qualitative clinical monitoring using scores such as the BSAS (9) or monitoring using peripheral nerve stimulation (train-of-four (TOF) (10)) or other devices such as accelerometry or electromyography.
As opposed to their use in the operating room where the interest of the monitoring is proven, there are discrepancy between studies on whether it is useful to monitor NMBAs in the ICU. For instance, Strange et al. did not observe any advantage of the use of a protocol of NMBAs administration (11), and Baumann et al. came to the same conclusions. However, more recently (12), Hraeich et al. found that the monitoring of NMBAs dosage guided by the TOF allowed to significantly reduce the dose administered during ADRS (13).
Thus, in the ICU, although guidelines recommend to monitor NMBAs administration (8), the level of evidence regarding the interest of monitoring and the device to use for such a monitoring is low.
The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective the investigators will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigator will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints, such as in-ICU mortality, duration of mechanical ventilation or acquired neuromyopathy or other complications of NMBAs.
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Neuromuscular Blockade in the Intentive Care Unit, an Observational Study. |
Actual Study Start Date : | November 18, 2019 |
Actual Primary Completion Date : | June 18, 2020 |
Estimated Study Completion Date : | November 1, 2021 |
Group/Cohort | Intervention/treatment |
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Neuromuscular blockade
Patients who will receive neuromuscular blockade during their ICU length stay will be follow until day 28 or their hospital discharge.
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Drug: Neuromuscular Blocking Agents
Patient who will receive neuromuscular blockade will be follow during their ICU lenght stay.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion criteria
Exclusion criteria :
France | |
CH d'Argenteuil | |
Argenteuil, France, 95100 | |
CHD Les Oudairies | |
la Roche sur Yon, France, 85925 | |
CH de Versailles | |
Le Chesnay, France, 78157 | |
CHU Kremlin-Bicetre | |
Le Kremlin-Bicêtre, France, 94270 | |
CH Le Mans | |
Le Mans, France, 72037 | |
CHU Nantes | |
Nantes, France, 44000 | |
CHU Nimes | |
Nîmes, France | |
CHR Orléans | |
Orléans, France | |
CHU La Pitié Salpétrière | |
Paris, France | |
CH de Pontoise | |
Pontoise, France, 95303 | |
CHRU Bretonneau | |
Tours, France, 37044 |
Tracking Information | |||||
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First Submitted Date | July 18, 2019 | ||||
First Posted Date | July 22, 2019 | ||||
Last Update Posted Date | September 23, 2020 | ||||
Actual Study Start Date | November 18, 2019 | ||||
Actual Primary Completion Date | June 18, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Proportion of patients who receive neuromuscular blockade [ Time Frame: ICU Length stay (usually 7 days) ] Proportion between patients who receive neuromuscular blockade and patients hospitalized in ICU and under mechanical ventilation
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Neuromuscular Blockade in the Intentive Care Unit, an Observational Study. | ||||
Official Title | Neuromuscular Blockade in the Intentive Care Unit, an Observational Study. | ||||
Brief Summary |
The study Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis. (Limit: 5000 characters) Neuromuscular blocking agents (NMBAs) are drug capable of inducing a complete paralysis of the muscle. Their use is frequent in the intensive care unit (ICU). Most of the time it is used as a single infusion to facilitate endotracheal intubation, but in the ICU the use of continuous infusion is common in several pathologies: acute distress respiratory syndrome, post-cardiac arrest survivor under hypothermia to prevent shivering, abdominal compartment syndrome, severe traumatic brain injury with uncontrolled intra-cranial pressure and severe asthma among others. A monitoring of the dose of NMBAs is recommended to guide the depth of paralysis and to guide recovery, but in the ICU, the interest of such a monitoring during continuous infusion is unclear and the level of evidence is low. The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective we will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigators will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints. |
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Detailed Description |
Neuromuscular blocking agents (NMBAs) are usually administered during anesthesia for endotracheal tube placement or surgical interventions. But their use is also common in the medical intensive care unit (ICU) (1, 2). Together with sedation and analgesia, they are mainly used in continuous infusion in Acute Respiratory Distress Syndrom (ARDS) (3, 4), but also in post-cardiac arrest survivor under hypothermia to prevent shivering (5), in abdominal compartment syndrome (6), in severe traumatic brain injury with uncontrolled intra-cranial pressure (7) and severe asthma among others. A monitoring of the treatment is recommended (8) and several monitoring techniques exists: qualitative clinical monitoring is known to be inefficient, qualitative clinical monitoring using scores such as the BSAS (9) or monitoring using peripheral nerve stimulation (train-of-four (TOF) (10)) or other devices such as accelerometry or electromyography. As opposed to their use in the operating room where the interest of the monitoring is proven, there are discrepancy between studies on whether it is useful to monitor NMBAs in the ICU. For instance, Strange et al. did not observe any advantage of the use of a protocol of NMBAs administration (11), and Baumann et al. came to the same conclusions. However, more recently (12), Hraeich et al. found that the monitoring of NMBAs dosage guided by the TOF allowed to significantly reduce the dose administered during ADRS (13). Thus, in the ICU, although guidelines recommend to monitor NMBAs administration (8), the level of evidence regarding the interest of monitoring and the device to use for such a monitoring is low. The investigators propose to conduct a prospective multicentric observational study to describe the current practice in the use of NMBAs in mechanically ventilated patients in the ICU. As a primary objective the investigators will describe the prevalence of NMBAs use in the ICU. As a secondary objective, the investigator will investigate the impact of protocol and/or monitoring devices of NMBAs on the dose administered and clinical outcome endpoints, such as in-ICU mortality, duration of mechanical ventilation or acquired neuromyopathy or other complications of NMBAs. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients hospitalized in ICU and under mechanical ventilation | ||||
Condition |
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Intervention | Drug: Neuromuscular Blocking Agents
Patient who will receive neuromuscular blockade will be follow during their ICU lenght stay.
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Study Groups/Cohorts | Neuromuscular blockade
Patients who will receive neuromuscular blockade during their ICU length stay will be follow until day 28 or their hospital discharge.
Intervention: Drug: Neuromuscular Blocking Agents
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Estimated Enrollment |
200 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | November 1, 2021 | ||||
Actual Primary Completion Date | June 18, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04028362 | ||||
Other Study ID Numbers | 2019-A01378-49 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | French Society for Intensive Care | ||||
Study Sponsor | French Society for Intensive Care | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | French Society for Intensive Care | ||||
Verification Date | September 2020 |