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Non-invasive Airway Management of Comatose Poisoned Emergency Patients

NCT04653597 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2023-07-17

No results posted yet for this study

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

Interventions

PROCEDURE

Close monitoring

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

PROCEDURE

Endotracheal intubation

invasive airway management in order to avoid risk of pulmonary aspiration

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Yonathan FREUND, PU-PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-16
Primary Completion
2023-04-12
Completion
2023-04-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653597 on ClinicalTrials.gov