Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery (FreeO2PostOp)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Major Thoracic and Abdominal Surgery

Treatments: Device: FreeO2 v2.2 active; Device: FreeO2 v2.2 with manual oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT02546830

RB14-060

CHRU de Brest (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

FreeO2 v2.2 active

Experimental group

Description:

Automatic Oxygen Administration

Treatment:

Device: FreeO2 v2.2 active

FreeO2 v2.2 with manual oxygenation

Active Comparator group

Description:

Manual Oxygen Administration

Treatment:

Device: FreeO2 v2.2 with manual oxygenation