Hypoxemia
Conditions
Keywords
Oxygen, PACU, Hypoxemia
Brief summary
After general anesthesia, there are the risks for airway obstruction, hypoventilation, atelectasis, ventilation-perfusion mismatch, hypercarbia and hypoxemia,so oxygen supplement in PACU seems necessary. This study aim is to compare the two methods of oxygen supplement which are 1.nasal cannula at O2 flow 4 L/min. 2.oxygen mask with O2 flow 5 L/min. The hypothesis in this study is the 2 methods can equally provide effective oxygen supplement to prevent anesthesia-related hypoxemia. Choosing nasal cannula would be reasonable because it is cheaper and more comfortable to patient.
Detailed description
The incidence and causes of hypoxemia in PACU will be identified, if necessary, a higher flow or changing oxygen delivery system can be used to prevent and treat hypoxemia. If any patients fail from oxygen weaning protocol in PACU and need longer oxygen therapy at ward, the duration of oxygen therapy will be recorded and also the compliance with oxygen delivery devices.
Interventions
DEVICEoxygen mask
DEVICEoxygen cannula
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* General anesthesia * Age 18-70 years * American Society of Anesthesiology (ASA)physical status 1-3 * Elective case
Exclusion criteria
* ASA physical status class 4 or more * Unstable pulmonary diseases * BMI \> 35 kg/m2 * oxygen saturation \< 94% when breathing in room air * Respiratory muscle weakness eg.myasthenia gravis * Central nervous system abnormalities eg.drowsiness, hypoventilation * Patients who have been intubated or needed ventilatory support before operation * Plan to remain intubated after the operation * Intracranial, intrathoracic and upper abdomen surgery * Patients who nasogastric tube is inserted * Airway problems eg. sinusitis * Nasal cavity related surgery or nasal packing eg. endoscopic sinus surgery * Patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hypoxemia in Both Groups | In PACU (1 hr after anesthesia) | Hypoxemia is defined as oxygen saturation \< 94%. We record number of participants with hypoxemia in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Causes of Hypoxemia | In PACU (1 hr after anesthesia) | Causes of hypoxemia in each participant in PACU will be recorded |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxygen Mask Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen mask | 250 |
| Oxygen Cannula Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
oxygen cannula | 250 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Oxygen Mask | Oxygen Cannula | Total |
|---|---|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 14 | 48.7 years STANDARD_DEVIATION 13.8 | 48.65 years STANDARD_DEVIATION 13.9 |
| Gender Female | 180 Participants | 161 Participants | 341 Participants |
| Gender Male | 70 Participants | 89 Participants | 159 Participants |
| Region of Enrollment Thailand | 250 participants | 250 participants | 500 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 250 | 0 / 250 |
| serious Total, serious adverse events | 0 / 250 | 0 / 250 |
Outcome results
Primary
Number of Participants With Hypoxemia in Both Groups
Hypoxemia is defined as oxygen saturation \< 94%. We record number of participants with hypoxemia in both groups
Time frame: In PACU (1 hr after anesthesia)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxygen Mask | Number of Participants With Hypoxemia in Both Groups | 0 number of participants |
| Oxygen Cannula | Number of Participants With Hypoxemia in Both Groups | 0 number of participants |
Secondary
The Causes of Hypoxemia
Causes of hypoxemia in each participant in PACU will be recorded
Time frame: In PACU (1 hr after anesthesia)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxygen Mask | The Causes of Hypoxemia | 0 causes of hypoxemia |
| Oxygen Cannula | The Causes of Hypoxemia | 0 causes of hypoxemia |