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Completed

NCT Number: NCT02027181

Automatic Administration of Oxygen During Respiratory Distress

Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure.

Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel.

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Key information

Conditions

Acute Respiratory Distress Syndrome Hypoxemia Hypoxia Lung Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hopital Hotel Dieux de Levis, Lévis, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission to the emergency for respiratory disease (or cardiac - acute pulmonary edema)justifying an oxygen administration to over 3 L / min to maintain a SpO2 ≥ 92%.
  • Inclusion within a time less than two hours after the start of the oxygen at the emergency.
  • Patient consent,or a close.

Exclusion criteria

  • Necessity of an oxygen flow exceeds 15 L / min to maintain a SpO2 higher than 92%.
  • Criteria of gravity justifying immediately a different technique of ventilatory support:
  • Disturbance of consciousness with a Glasgow Coma Score ≤ 12
  • Serious ventricular rhythm disorders
  • Hemodynamic instability (SBP <80mmHg or recourse to vasopressors)
  • Cardiac or respiratory arrest
  • pH < 7.35 and PaCO2 > 55 mm Hg
  • Necessity of a urgent surgery, or coronary revascularization
  • Age <18 years
  • Pregnant women, lactating
  • Patient not relevant
  • Unavailability of the prototype FreeO2

Treatment and study plan

Device FreeO2 v2.0

Device
  • Automatic adjustment of oxygen through the "Free O2" device.
  • "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

Primary outcomes

  1. Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment

    Time frame: 3 hours or 1 hour after after cessation of oxygenation

    The target zone of oxygen saturation is : SpO2 = 92-96% The "acute phase of treatment" is defined by the 3 first hours of treatment by oxygenation and/or until one hour after the end of this last.

Secondary outcomes

  1. nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures

    Time frame: 3 days max

  2. Time spent in a area of severe desaturation (SpO2 <88%) and a hyperoxia area (SpO2> 98%).

    Time frame: 3 hours or 1 hour after after cessation of oxygenation

  3. Maintaining EtCO2 in a selected area

    Time frame: 3 hours or 1 hour after after cessation of oxygenation

  4. Oxygen consumption measured at the end of administration

    Time frame: 3 hours or 1 hour after after cessation of oxygenation

  5. Duration of administration during hospitalization

    Time frame: 28 days max

  6. Number of complications related to the administration of oxygen

    Time frame: 28 days max

  7. Frequency of use of invasive or noninvasive ventilation during hospitalization.

    Time frame: 28 days max

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress

Acronym: FreeO2-Hypox

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2014
Registry last updated
Oct 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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