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OpenTrials
Completed

NCT Number: NCT02546830

Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery

The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in the post anesthesia care unit in a patient population admitted for major abdominal and thoracic surgery.

The investigators' hypothesis is that FreeO2 system will provide a better control of the oxygen saturation and reduce postoperative hypoxaemia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Laval - Québéc, Québéc, 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

  • Preoperative anesthetic visit for major thoracic or abdominal surgery ( ARISCAT risk score ≥ 26) with general anesthesia
  • Patient consent

Randomization Criteria:

  • Admission in post-anesthesia care unit after major thoracic or abdominal surgery
  • Randomization and device establishment within a time less than one hour after the endotracheal intubation
  • Availability of the prototype FreeO2
  • Absence of 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 an oxygen flow less than 15 L / min to maintain a SpO2 higher than 92%.
  • Absence of necessity of a urgent surgery
  • Oxygen saturation measured by Spo2 sensor

Exclusion criteria

  • BMI ≥ 35 kg/m2
  • Obstructive sleep Apnea (with or without Mechanical therapy)
  • Emergency Surgery for life-threatening
  • Age <18 years
  • Pregnant women, lactating
  • perturbed or non-cooperative patient

Treatment and study plan

FreeO2 v2.2 active

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

FreeO2 v2.2 with manual oxygenation

Device
  • Manual adjustment of oxygen without the assistance of the "FreeO2" device.
  • Only "FreeO2" device in mode medical data collecting(SpO2,EtCO2...).

Primary outcomes

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

    Time frame: 3 days

    The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD

Secondary outcomes

  1. nursing workload

    Time frame: 3 days

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

  2. Time spent in a area of severe desaturation (SpO2 <85%)

    Time frame: 3 days

    Time spent in a area of severe desaturation (SpO2 <85%) evaluated by freeO2 device

  3. Time spent in a hyperoxia area (SpO2> 98%).

    Time frame: 3 days

    Time spent in a hyperoxia area (SpO2> 98%) evaluated by freeO2 device

  4. Maintaining EtCO2 in a selected area

    Time frame: 3 days

    Maintaining EtCO2 in a selected area evaluated by freeO2 device

  5. Oxygen consumption measured at the end of administration

    Time frame: 3 days

    Oxygen consumption measured at the end of administration

  6. Duration of oxygen administration during hospitalization

    Time frame: 3 days

    Duration of oxygen administration during hospitalization

  7. Number of complications related to the administration of oxygen

    Time frame: 28 days max

    Number of complications related to the administration of oxygen

  8. Frequency of use of ventilation (invasive or noninvasive )

    Time frame: 28 days max

    Frequency of use of ventilation (invasive or noninvasive )

  9. Duration of hospitalization

    Time frame: 28 days max

    Duration of hospitalization

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery

Acronym: FreeO2PostOp

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2015
Registry last updated
Jan 16, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.