Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit
- Conditions
- HypoxemiaAtelectasisPostoperative ComplicationsAnesthesiaHyperoxia
- Interventions
- Other: FiO2 1Other: FiO2 0.5
- Registration Number
- NCT04879290
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.
- Detailed Description
During pre-anesthesia visit, eligible patients receive oral and written information of the study and potential risks.
In the operating room all patients giving a written informed consent will undergo at the end of surgery a screening to determine eligibility for study entry.
Before emergence from general anesthesia, patients who meet the eligibility requirements will be randomized in a open label manner to receive a 0.5 or 1 FiO2.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- Patients undergoing general anesthesia, with invasive mechanical ventilation including an airway device (supraglottic airway device or tracheal tube) at their arrival in PACU.
- ASA physical status classification 1, 2, or 3 stabilized.
- Surgery performed in emergency operating room department including vascular, digestive, urological and minor trauma surgery or surgery performed in head and neck anesthesia pole block including anterior cervical spine, lumbar disc herniation, cranioplasty, nerve stimulator, vertebroplasty, narrow lumbar canal, simple arthrodesis (less than or equal to two stages), otological, ophthalmological and skin surgery.
- Per-operative hemodynamic instability.
- Patients with a BMI greater than 35.
- Patients classified as difficult to intubate and / or ventilate.
- Heavy surgeries (operating time greater than 4 hours).
- Patient requiring postoperative non invasive mechanical ventilation
- Patients with diagnosed COPD
- SPO2 in room air < 96% before the intervention.
- Any patient under guardianship.
- Pre-operative and / or intra-operative morphine intake.
- Surgical management of the upper airways (ex : tonsillectomy)
- Pregnant and lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group FiO2=1 FiO2 1 FiO2 = 1 (100%) 10mn before emergence of general anesthesia Intervention Group FiO2 0.5 FiO2 0.5 Fi02 = 0.5 (50%) 10mn before emergence of general anesthesia
- Primary Outcome Measures
Name Time Method Decrease of oxygen saturation Duration of stay in post-anesthesia care unit, approximately one hour Proportions of patients that present a decrease of 4 points of peripheral capillary oxygen saturation (SpO2) measured with pulse oximetry after extubation compared to their baseline room air SpO2
- Secondary Outcome Measures
Name Time Method PACU length of stay One hour Length of stay in post-anesthesia care unit
Duration of emergence Up to one hour Elapsed Time between cessation of sedation and extubation (minutes)
Majored decrease of oxygen saturation One hour Proportions of patients that present a decrease of 6 points of SpO2 after extubation compared to their baseline room air SpO2
Primary Outcome Timing Up to one hour Elapsed time between extubation and decrease of oxygen saturation (minutes)
Number of risk factors One hour Number of factors associated with episodes of hypoxemia : bronchospasm, bronchial congestion (profuse secretions with the need to aspirate the patient several times), loss of upper airway muscle tonus (fall of the tongue).
Corrective measures One hour Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success.
Trial Locations
- Locations (1)
University Hospital, Caen
🇫🇷Caen, France