The Performance of Two Oxygen Delivery Devices Used After General Anesthesia.

Mahidol University

Status: Completed

Conditions: Hypoxemia

Treatments: Device: oxygen cannula; Device: oxygen mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01917526

066/2556 (EC3)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

oxygen mask

Active Comparator group

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.

Treatment:

Device: oxygen mask

Oxygen cannula

Active Comparator group

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.

Treatment:

Device: oxygen cannula