Major Thoracic and Abdominal Surgery Clinical Trial
— FreeO2PostOpOfficial title:
Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery
| Verified date | January 2019 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hôpital Laval - Québéc | Québéc | |
| France | Brest, University Hospital | Brest | |
| France | CHU Clermont-Ferrand | Clermont-Ferrand | |
| France | CHU Montpellier | Montpellier | |
| France | CHU Poitiers | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
Canada, France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | nursing workload | nursing workload assessed by the number of manual Oxygen flow adjustments and airway management procedures | 3 days | |
| Secondary | 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 | |
| Secondary | Time spent in a hyperoxia area (SpO2> 98%). | Time spent in a hyperoxia area (SpO2> 98%) evaluated by freeO2 device | 3 days | |
| Secondary | Maintaining EtCO2 in a selected area | Maintaining EtCO2 in a selected area evaluated by freeO2 device | 3 days | |
| Secondary | Oxygen consumption measured at the end of administration | Oxygen consumption measured at the end of administration | 3 days | |
| Secondary | Duration of oxygen administration during hospitalization | Duration of oxygen administration during hospitalization | 3 days | |
| Secondary | Number of complications related to the administration of oxygen | Number of complications related to the administration of oxygen | 28 days max | |
| Secondary | Frequency of use of ventilation (invasive or noninvasive ) | Frequency of use of ventilation (invasive or noninvasive ) | 28 days max | |
| Secondary | Duration of hospitalization | Duration of hospitalization | 28 days max |