Major Thoracic and Abdominal Surgery
Conditions
Brief summary
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.
Interventions
DEVICEFreeO2 v2.2 active
* Automatic adjustment of oxygen through the Free O2 device. * FreeO2 device in mode medical data collecting(SpO2,EtCO2...).
DEVICEFreeO2 v2.2 with manual oxygenation
* Manual adjustment of oxygen without the assistance of the FreeO2 device. * Only FreeO2 device in mode medical data collecting(SpO2,EtCO2...).
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time spent in the target zone of oxygen saturation | 3 days | The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in a area of severe desaturation (SpO2 <85%) | 3 days | Time spent in a area of severe desaturation (SpO2 \<85%) evaluated by freeO2 device |
| Time spent in a hyperoxia area (SpO2> 98%). | 3 days | Time spent in a hyperoxia area (SpO2\> 98%) evaluated by freeO2 device |
| Maintaining EtCO2 in a selected area | 3 days | Maintaining EtCO2 in a selected area evaluated by freeO2 device |
| Oxygen consumption measured at the end of administration | 3 days | Oxygen consumption measured at the end of administration |
| nursing workload | 3 days | nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures |
| Number of complications related to the administration of oxygen | 28 days max | Number of complications related to the administration of oxygen |
| Frequency of use of ventilation (invasive or noninvasive ) | 28 days max | Frequency of use of ventilation (invasive or noninvasive ) |
| Duration of hospitalization | 28 days max | Duration of hospitalization |
| Duration of oxygen administration during hospitalization | 3 days | Duration of oxygen administration during hospitalization |
Countries
Canada, France
Outcome results
None listed