Automatic Oxygen Administration After Major Abdominal and Thoracic Surgery
- Conditions
- Major Thoracic and Abdominal Surgery
- Interventions
- Device: FreeO2 v2.2 with manual oxygenationDevice: FreeO2 v2.2 active
- Registration Number
- NCT02546830
- Lead Sponsor
- University Hospital, Brest
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FreeO2 v2.2 with manual oxygenation FreeO2 v2.2 with manual oxygenation Manual Oxygen Administration FreeO2 v2.2 active FreeO2 v2.2 active Automatic Oxygen Administration
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Maintaining EtCO2 in a selected area 3 days Maintaining EtCO2 in a selected area evaluated by freeO2 device
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 )
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
Oxygen consumption measured at the end of administration 3 days Oxygen consumption measured at the end of administration
Duration of hospitalization 28 days max Duration of hospitalization
nursing workload 3 days nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures
Duration of oxygen administration during hospitalization 3 days Duration of oxygen administration during hospitalization
Trial Locations
- Locations (5)
CHU Poitiers
🇫🇷Poitiers, France
Hôpital Laval - Québéc
🇨🇦Québéc, Canada
Brest, University Hospital
🇫🇷Brest, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU Montpellier
🇫🇷Montpellier, France