Back to resultsThe Performance of Two Oxygen Delivery Devices Used After General Anesthesia.
Primary Purpose
Hypoxemia
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
oxygen mask
oxygen cannula
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxemia focused on measuring Oxygen, PACU, Hypoxemia
Eligibility Criteria
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
Sites / Locations
- Siriraj hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
oxygen mask
Oxygen cannula
Arm Description
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 with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The Causes of Hypoxemia
Causes of hypoxemia in each participant in PACU will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01917526
Brief Title
The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.
Official Title
The Performance Comparison of Two Oxygen Delivery Devices [Nasal Cannula and Mask] Used After General Anesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
Oxygen, PACU, Hypoxemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxygen mask
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oxygen cannula
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
oxygen mask
Other Intervention Name(s)
Oxygen mask or simple mask
Intervention Type
Device
Intervention Name(s)
oxygen cannula
Primary Outcome Measure Information:
Title
Number of Participants With Hypoxemia in Both Groups
Description
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)
Secondary Outcome Measure Information:
Title
The Causes of Hypoxemia
Description
Causes of hypoxemia in each participant in PACU will be recorded
Time Frame
In PACU (1 hr after anesthesia)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manee Raksakietisak, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
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The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.
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