Non-invasive Airway Management of Comatose Poisoned Emergency Patients

NCT04653597 | Completed Phase 3 DMC

• 2 other identifiers: APHP2000132020-A02036-33
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

A decreased level of consciousness is a common reason for presentation to the emergency department (ED) and is often the result of intoxication (up to 1% of all ED visits and 3% of ICU admission). In France, approximately 165 000 poisoned patients are managed each year. Originally developed in head injured patients, the Glasgow Coma Scale (GCS) is a validated reproducible score evaluating the level of consciousness: a GCS ≤ 8 is strongly associated with reduced gag reflex and increased incidence of aspiration pneumonia. Although recommended for patients with traumatic brain injury and coma, it remains unknown whether the benefit of an invasive management of airways with sedation, intubation and mechanical ventilation should be applied to other causes of coma in particular for acute poisoned patients. The investigator hypothesize that a conservative management with close monitoring without immediate endotracheal intubation of these patients is effective and associated with less in-hospital complications (truncated at 28 days) compared to routine practice management (in which the decision of immediate intubation is left to the discretion of the emergency physician).

Conditions

Poisoning; Consciousness, Level Altered; Comatose

Keywords

ED; ICU; MICU; Coma; Comatose poisoning; intubation; Endotracheal intubation; GCS; Glasgow Coma Scale

Outcome Measures

Primary Outcomes (3)

• Hierarchical composite endpoint of (truncated at 28 days): - In hospital death

  this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.

  at 28 days

• Hierarchical composite endpoint of (truncated at 28 days):- Length of ICU stay

  this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.

  at 28 days

• Hierarchical composite endpoint of (truncated at 28 days): - Length of hospital stay

  this endpoint will be reported using both the Finkelstein model (Finkelstein Stat med 1999; Beitler JAMA 2019) and the win ratio methods (Pocok Eur H J 2016), with priority listed in this order from highest to lowest. Patients will be followed until hospital discharge (or truncated at 28 days if still hospitalized) and data collected in the electronic health record the investigator with the help of a clinical research technician.

  at 28 days

Secondary Outcomes (10)

• In-hospital death (truncated at 28 days)

  at 28 days

• ICU length of stay (truncated at 28 days)

  at 28 days

• Hospital length of stay (truncated at 28 days)

  at 28 days

• Proportion of patient with Mechanical ventilation at day 28

  at 28 days

• Lenght of mechanical ventilation until hospital discharge or at day28

  at 28 days

Study Arms (2)

Conservative airway management

EXPERIMENTAL

decision to intubate will be withheld as long as the patient's state allows it. The patient will be closely monitored and decision of intubation will be made upon presence of regurgitation, seizure, shock, or sign of respiratory distress.

Procedure: Close monitoring

Routine practice

OTHER

decision of intubation left at the discretion of the emergency physician

Procedure: Endotracheal intubation

Interventions

Close monitoring PROCEDURE

surveillance every 30 minutes of blood pressure, SpO2, respiratory rate, heart rate and GCS until the patient recovers a GCS\>8 or responds adequately to a simple order

Conservative airway management

Endotracheal intubation PROCEDURE

invasive airway management in order to avoid risk of pulmonary aspiration

Routine practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Clinical suspicion of acute poisoning (either alcohol, drug or medication)
• Decreased level of consciousness with a GCS ≤ 8 assessed by an emergency physician either in the ED or in the out of hospital field with the mobile intensive care unit (MICU).
• Patients affiliated to French social security ("AME" excepted)

You may not qualify if:

• Respiratory failure (SpO2 \< 90% with oxygen provided by nasal cannula (≤ 4 l/min.), clinical signs of respiratory distress)
• Sustained systolic blood pressure \< 90 mmHg despite fluid resuscitation of 1 liter of critalloid
• Witnessed seizure
• Acute cerebral aggression (Traumatic brain injury, intracranial hematoma, stroke)
• Suspected Cardiotropic drugs poisoning (beta blockers, calcium channel inhibitor, angiotensin conversion enzyme), QRS or QT enlargement on ECG.
• Suspected sole intoxication with toxic for which there is an antidote
• Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
• Known Pregnant women and breast feeding woman
• Participation in another intervention trial

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Emergency department Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (2)

• Siaha BFN, Ossima AN, Mimouni M, Freund Y, Durand-Zaleski I; NICO Study Group. Cost-effectiveness of non-invasive airway management of comatose patients with acute poisoning. Intensive Care Med. 2024 Jul;50(7):1169-1171. doi: 10.1007/s00134-024-07452-1. Epub 2024 Jun 24. No abstract available.

  PMID: 38913094 DERIVED

• Freund Y, Viglino D, Cachanado M, Cassard C, Montassier E, Douay B, Guenezan J, Le Borgne P, Yordanov Y, Severin A, Roussel M, Daniel M, Marteau A, Peschanski N, Teissandier D, Macrez R, Morere J, Chouihed T, Roux D, Adnet F, Bloom B, Chauvin A, Simon T. Effect of Noninvasive Airway Management of Comatose Patients With Acute Poisoning: A Randomized Clinical Trial. JAMA. 2023 Dec 19;330(23):2267-2274. doi: 10.1001/jama.2023.24391.

  PMID: 38019968 DERIVED

MeSH Terms

Conditions

Poisoning; Consciousness Disorders; Coma

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Unconsciousness

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Yonathan FREUND, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: December 4, 2020
• Study Start: May 16, 2021
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

FR (1)