Critical CareCURATIVNCT04028362
Neuromuscular Blockade in the Intentive Care Unit, an Observational Study.
An observational study of Critical Care and Mechanical Ventilation, run by French Society for Intensive Care at 11 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Mechanical Ventilation, Neuromuscular Blockade
- What is being tested?
- Neuromuscular Blocking Agents
- How many people
- 282 participants
- Where
- 11 sitesFrance
- Study dates
- 2 Nov 2019to 1 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in ICU and under mechanical ventilation
Who may be able to join
- Adult Patients hospitalized in an intensive care unit
- Patient under invasive mechanical ventilation
- Administration of at least a single dose of neuromuscular blocking agent
Who cannot join
- Administration of a single dose of Succinylcholine or Rocuronium for a rapid-sequence intubation
- Moribund patient whose life expectancy is less than 24 hours
- Patient under 18 years old
- Patient under legal guardianship.
- Pregnant women
- Patient already included previously in the study
- Absence of health insurance in France
- Neuromuscular blocking agent administered outside the ICU (i.e. in the operating room)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CH d'Argenteuil
Argenteuil, 95100
CHD Les Oudairies
La Roche-sur-Yon, 85925
CH de Versailles
Le Chesnay, 78157
CHU Kremlin-Bicetre
Le Kremlin-Bicêtre, 94270
CH Le Mans
Le Mans, 72037
CHU Nantes
Nantes, 44000
CHU Nimes
Nîmes
CHR Orléans
Orléans
CHU La Pitié Salpétrière
Paris
CH de Pontoise
Pontoise, 95303
CHRU Bretonneau
Tours, 37044
About this study
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.
Read the 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.
- Being tested
- Neuromuscular Blocking Agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Blocking AgentsDrug
Patient who will receive neuromuscular blockade will be follow during their ICU lenght stay.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular blockade | Patients who will receive neuromuscular blockade during their ICU length stay will be follow until day 28 or their hospital discharge. Receives: Drug: Neuromuscular Blocking Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who receive neuromuscular blockade
Proportion between patients who receive neuromuscular blockade and patients hospitalized in ICU and under mechanical ventilation
Measured: ICU Length stay (usually 7 days)
Secondary outcomes (8)
Indications of neuromuscular blockade
Description of indications for neuromuscular blockade
Measured: ICU Length stay (usually 7 days)
Monitoring of neuromuscular blockade
Proportion of patients in whom neuromuscular blockade was monitored
Measured: ICU Discharge (usually 7 days)
Neuromuscular blocking agents administered dose
Total dose and duration of NMBAs
Measured: ICU Discharge (usually 7 days)
Tolerance of neuromuscular blocking agents
Acquired ICU weakness, pressure ulcer, ventilator associated pneumonia, other potential side effects neuromuscular blocking agents
Measured: ICU Discharge (usually 7 days)
Number of tracheostomy
Proportion of patients who received tracheostomy during their ICU stay
Measured: ICU Discharge (usually 7 days)
Duration of ICU stay
Duration of ICU stay
Measured: ICU Discharge (usually 7 days)
Duration of mechanical ventilation
Duration of mechanical ventilation
Measured: Time from intubation to successfull extubation (usually 5 days)
ICU Mortality
Proportion of patients dead during their ICU length stay
Measured: Time of ICU discharge (usually 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start2 Nov 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Society for Intensive Care
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028362
- Sponsor's protocol ID
- 2019-A01378-49
- Acronym
- CURATIV
- Status last verified
- Dec 2021
- First submitted
- 18 Jul 2019
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD can be obtained from PI after careful evaluation of request by clinical research committee of the French Intensive Care Society
Publications
Arroliga A, Frutos-Vivar F, Hall J, Esteban A, Apezteguia C, Soto L, Anzueto A; International Mechanical Ventilation Study Group. Use of sedatives and neuromuscular blockers in a cohort of patients receiving mechanical ventilation. Chest. 2005 Aug;128(2):496-506. doi: 10.1378/chest.128.2.496.
PubMed 16100131Arroliga AC, Thompson BT, Ancukiewicz M, Gonzales JP, Guntupalli KK, Park PK, Wiedemann HP, Anzueto A; Acute Respiratory Distress Syndrome Network. Use of sedatives, opioids, and neuromuscular blocking agents in patients with acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2008 Apr;36(4):1083-8. doi: 10.1097/CCM.0B013E3181653895.
PubMed 18401254Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
PubMed 20843245Lascarrou JB, Le Gouge A, Dimet J, Lacherade JC, Martin-Lefevre L, Fiancette M, Vinatier I, Lebert C, Bachoumas K, Yehia A, Lagarrigue MH, Colin G, Reignier J. Neuromuscular blockade during therapeutic hypothermia after cardiac arrest: observational study of neurological and infectious outcomes. Resuscitation. 2014 Sep;85(9):1257-62. doi: 10.1016/j.resuscitation.2014.05.017. Epub 2014 Jun 2.
PubMed 24892266Hermann B, Decormeille G, Gobe T, Mangeard N, Maamar A, Sayadi S, Pernod B, Robquin N, Ponthus JP, Le Potier S, Bouju P, Balabanian A, Frouin A, Moschietto S, Jacq G, Villemont E, Hoube C, Queyreau A, Morand C, Boissier F, Lascarrou JB, Valera S, Hraiech S, Clouet L, Piton G, Noel C, Joosten A, Tabra Osorio C, Constan A, Cecchini J, Mercier G, Bruyneel A, Villamaux C, Pousset F, Heming N, Poiroux L, Llitjos JF, Barbar SD; SRLF Trial Group. Neuromuscular blockade and their monitoring in the intensive care unit: a multicenter observational prospective study. Ann Intensive Care. 2025 Oct 22;15(1):167. doi: 10.1186/s13613-025-01591-4.
PubMed 41123780
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Blockade in the Intentive Care Unit, an Observational Study.
- ClinicalTrials.gov ID
- NCT04028362
- Acronym / sponsor ID
- CURATIV / 2019-A01378-49
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- French Society for Intensive CareUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular blockade | – | Drug: Neuromuscular Blocking AgentsPatients who will receive neuromuscular blockade during their ICU length stay will be follow until day 28 or their hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in ICU and under mechanical ventilation
Key inclusion criteria (3 listed)
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Blocking AgentsPatient who will receive neuromuscular blockade will be follow during their ICU lenght stay. | Drug | Neuromuscular blockade |
Primary outcome
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
8 secondary outcomes
Indications of neuromuscular blockade
Time frame: ICU Length stay (usually 7 days)
Monitoring of neuromuscular blockade
Time frame: ICU Discharge (usually 7 days)
Neuromuscular blocking agents administered dose
Time frame: ICU Discharge (usually 7 days)
Tolerance of neuromuscular blocking agents
Time frame: ICU Discharge (usually 7 days)
Number of tracheostomy
Time frame: ICU Discharge (usually 7 days)
Duration of ICU stay
Time frame: ICU Discharge (usually 7 days)
Duration of mechanical ventilation
Time frame: Time from intubation to successfull extubation (usually 5 days)
ICU Mortality
Time frame: Time of ICU discharge (usually 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Background: PubMed 16100131Arroliga A, Frutos-Vivar F, Hall J, Esteban A, Apezteguia C, Soto L, Anzueto A; International Mechanical Ventilation Study Group. Use of sedatives and neuromuscular blockers in a cohort of patients receiving mechanical ventilation. Chest. 2005 Aug;128(2):496-506. doi: 10.1378/chest.128.2.496.
- Background: PubMed 18401254Arroliga AC, Thompson BT, Ancukiewicz M, Gonzales JP, Guntupalli KK, Park PK, Wiedemann HP, Anzueto A; Acute Respiratory Distress Syndrome Network. Use of sedatives, opioids, and neuromuscular blocking agents in patients with acute lung injury and acute respiratory distress syndrome. Crit Care Med. 2008 Apr;36(4):1083-8. doi: 10.1097/CCM.0B013E3181653895.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Background: PubMed 20843245Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
- Background: PubMed 24892266Lascarrou JB, Le Gouge A, Dimet J, Lacherade JC, Martin-Lefevre L, Fiancette M, Vinatier I, Lebert C, Bachoumas K, Yehia A, Lagarrigue MH, Colin G, Reignier J. Neuromuscular blockade during therapeutic hypothermia after cardiac arrest: observational study of neurological and infectious outcomes. Resuscitation. 2014 Sep;85(9):1257-62. doi: 10.1016/j.resuscitation.2014.05.017. Epub 2014 Jun 2.
- Derived from this study: PubMed 41123780Hermann B, Decormeille G, Gobe T, Mangeard N, Maamar A, Sayadi S, Pernod B, Robquin N, Ponthus JP, Le Potier S, Bouju P, Balabanian A, Frouin A, Moschietto S, Jacq G, Villemont E, Hoube C, Queyreau A, Morand C, Boissier F, Lascarrou JB, Valera S, Hraiech S, Clouet L, Piton G, Noel C, Joosten A, Tabra Osorio C, Constan A, Cecchini J, Mercier G, Bruyneel A, Villamaux C, Pousset F, Heming N, Poiroux L, Llitjos JF, Barbar SD; SRLF Trial Group. Neuromuscular blockade and their monitoring in the intensive care unit: a multicenter observational prospective study. Ann Intensive Care. 2025 Oct 22;15(1):167. doi: 10.1186/s13613-025-01591-4.
- Individual participant dataSharing planned: Undecided. IPD can be obtained from PI after careful evaluation of request by clinical research committee of the French Intensive Care Society
Related trials for Critical Care
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Not yet recruiting
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation
Mechanical Ventilation, Critical Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care and Mechanical Ventilation, run by French Society for Intensive Care at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who receive neuromuscular blockade (time frame: ICU Length stay (usually 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028362, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021; AzTrials last refreshed its copy on 2 Nov 2026.