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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxygen mask | Active Comparator | 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 cannula | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxygen mask | Device |
|
| |
| oxygen cannula |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | In PACU (1 hr after anesthesia) |
| Measure | Description | Time Frame |
|---|---|---|
| The Causes of Hypoxemia | Causes of hypoxemia in each participant in PACU will be recorded | In PACU (1 hr after anesthesia) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manee Raksakietisak, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients aged between 18-70 years who were scheduled for elective surgery under general anesthesia and had American Society of Anesthesiologists (ASA) physical status 1-3.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Oxygen Cannula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | number of participants | In PACU (1 hr after anesthesia) |
|
1 hour after anesthesia (in post-anesthesia care unit)
Adverse events such as hypoxemia, re-intubation, unplanned ICU admission will be recorded. There were no serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department of Anesthesiology, Siriraj Hospital | Mahidol University | 66-2-41979889 | 501 | manee95@hotmail.com |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Device |
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Causes of Hypoxemia | Causes of hypoxemia in each participant in PACU will be recorded | Posted | Number | causes of hypoxemia | In PACU (1 hr after anesthesia) |
|
|
|
| 0 |
| 250 |
| 0 |
| 250 |
| EG001 | 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 | 0 | 250 | 0 | 250 |
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