Anesthesia Clinical Trial
Official title:
Effects of Preoxygenation With Lower Inspiratory Oxygen Fraction During Induction of Anesthesia
Verified date | September 2018 |
Source | E-DA Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
During the induction period of general anesthesia, surgical patients are inevitably experienced a short period of apnea for endotracheal intubation or other airway manipulation. In order to minimize the risks of hypoxemia during the establishment of artificial airway, pure oxygen (FiO2=100%) is commonly applied to the patients throughout the preoxygenation and induction period. However, high concentration of oxygen therapy has been shown to result in hyperoxemia and substantial oxygen exposure during perioperative period or critical care. There is currently no clinical evidence indicating that preoxygenation with a lower oxygen partial pressure (such as FiO2=60%) during the induction of anesthesia increases the incidence of hypoxemia or other complications. The findings of this proposed clinical study may provide fundamental evidence for the use of different oxygen concentrations in clinical anesthesia during the induction period, and determine the effects of inspired oxygen concentrations on the general postoperative outcomes during general anesthesia.
Status | Terminated |
Enrollment | 304 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. A patient who is scheduled for an elective surgery and required for general anesthesia with endotracheal intubation. 2. Age of the patient is between 20 and 65 years old. 3. Patient's American Society of Anesthesiologists (ASA) Physical Status is I- III. Exclusion Criteria: Patients who: 1. Have difficult airway for ventilation or intubation. 2. Have severe lung disease (including any acute respiratory infection). 3. Had past history of coronary artery disease or myocardial infarction. 4. Have severe heart failure (NYHA Fc =III). 5. Have liver cirrhosis (Child-Pugh's score =B). 6. Have acute or chronic kidney disease (Creatinine =2 mg/dl). 7. Have severe anemia (hemoglobin =8 mg /dl). 8. Have a body mass index (BMI) =35. 9. Are currently pregnant. 10. Have inadequate fasting time, intestinal obstruction or severe gastroesophageal reflux. 11. Scheduled for an emergency surgery, cardiac surgery, craniotomy, or pulmonary surgery. 12. Have mental incapacitant, confusion, dementia, mental retardation, or are unable to complete the consent independently. 13. Refuse to participate in this study. |
Country | Name | City | State |
---|---|---|---|
Taiwan | E-Da Hospital | Yanchao | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
E-DA Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of hypoxemia | The definition of hypoxemia is the measurement of peripheral oxygen saturation (sPO2) lower than < 92%. Induction phase of anesthesia is defined as the time frame from preoxygenation before intravenous administration of anesthetics to successful establishment of an endotracheal tube. | Within 30 minutes after induction of anesthesia | |
Secondary | Development of acute respiratory distress syndrome (ARDS) | ARDS is defined as any calculated PaO2/FiO2 less than 300mmHg with radiographic evidence of bilateral lung infiltration in the absence of left heart failure | Within 7 days after surgery | |
Secondary | Development of atelectasis | Atelectasis is defined as partial or complete collapse of lung lobe(s) on chest radiography | Within 7 days after surgery | |
Secondary | Development of pneumonia | Pneumonia is defined as acute infection of lung parenchyma | Within 7 days after surgery | |
Secondary | Development of surgical site infection (SSI) | SSI is defined as infection arising from surgical incision | Within 7 days after surgery | |
Secondary | Development of severe postoperative pain | Severe postoperative pain is defined as visual analogue scale (VAS) >4 despite of administration of analgesics. VAS is defined as a straight line with the endpoints representing the extreme limits of pain; "no pain at all= 0" and "pain as bad as it could be= 10" | Within 7 days after surgery | |
Secondary | Length of hospital stay (LOS) | LOS is defined as day(s) of hospitalization after surgery | Within 7 days after surgery |
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