Anesthesia, Atelectasis, Hyperoxia, Hypoxemia, Postoperative Complications
Conditions
Keywords
Post-anesthesia care unit, Extubation
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.
Interventions
OTHERFiO2 0.5
Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 0.5 (50%)
OTHERFiO2 1
Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 1 (100%)
Sponsors
University Hospital, Caen
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
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of emergence | Up to one hour | Elapsed Time between cessation of sedation and extubation (minutes) |
| 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). |
| 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 |
| Corrective measures | One hour | Number of corrective measures (method and oxygen supply equipment used) after hypoxemia and proportion of success. |
| PACU length of stay | One hour | Length of stay in post-anesthesia care unit |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDr KAMGA TOTOUOM, MD
Anesthesiologist
STUDY_DIRECTORPr HANOUZ, PhD
Anesthesiologist
PRINCIPAL_INVESTIGATORDr BOUTROS, MD
Anesthesiologist
Outcome results
None listed