Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Thoracic and Abdominal Surgery

Intervention / Treatment
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* Device: FreeO2 v2.2 active
* Device: FreeO2 v2.2 with manual oxygenation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FreeO2 v2.2 active<br>Automatic Oxygen Administration | Device: FreeO2 v2.2 active<br>* Automatic adjustment of oxygen through the Free O2 device. FreeO2 device in mode medical data collecting(SpO2,EtCO2...).<br>|
| Active Comparator: FreeO2 v2.2 with manual oxygenation<br>Manual Oxygen Administration | Device: FreeO2 v2.2 with manual oxygenation<br>* Manual adjustment of oxygen without the assistance of the FreeO2 device. Only FreeO2 device in mode medical data collecting(SpO2,EtCO2...).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time spent in the target zone of oxygen saturation | The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nursing workload | nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures | 3 days | 
| Time spent in a area of severe desaturation (SpO2 <85%) | Time spent in a area of severe desaturation (SpO2 <85%) evaluated by freeO2 device | 3 days | 
| Time spent in a hyperoxia area (SpO2> 98%). | Time spent in a hyperoxia area (SpO2> 98%) evaluated by freeO2 device | 3 days | 
| Maintaining EtCO2 in a selected area | Maintaining EtCO2 in a selected area evaluated by freeO2 device | 3 days | 
| Oxygen consumption measured at the end of administration | Oxygen consumption measured at the end of administration | 3 days | 
| Duration of oxygen administration during hospitalization | Duration of oxygen administration during hospitalization | 3 days | 
| Number of complications related to the administration of oxygen | Number of complications related to the administration of oxygen | 28 days max | 
| Frequency of use of ventilation (invasive or noninvasive ) | Frequency of use of ventilation (invasive or noninvasive ) | 28 days max | 
| Duration of hospitalization | Duration of hospitalization | 28 days max |