NCT02546830
Completed
Not Applicable
Automatic Oxygen Administration in Early and Late Postoperative Hypoxaemia Prevention After Major Abdominal and Thoracic Surgery
ConditionsMajor Thoracic and Abdominal Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Thoracic and Abdominal Surgery
- Sponsor
- University Hospital, Brest
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Percentage of time spent in the target zone of oxygen saturation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
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
Outcomes
Primary Outcomes
Percentage of time spent in the target zone of oxygen saturation
Time Frame: 3 days
The target zone of oxygen saturation is : SpO2 = 88-92% for COPD patient and 92-96% for non COPD
Secondary Outcomes
- Duration of hospitalization(28 days max)
- Maintaining EtCO2 in a selected area(3 days)
- Number of complications related to the administration of oxygen(28 days max)
- Frequency of use of ventilation (invasive or noninvasive )(28 days max)
- Time spent in a area of severe desaturation (SpO2 <85%)(3 days)
- Time spent in a hyperoxia area (SpO2> 98%).(3 days)
- Oxygen consumption measured at the end of administration(3 days)
- nursing workload(3 days)
- Duration of oxygen administration during hospitalization(3 days)
Study Sites (5)
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