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

Hypoxemia Clinical Trial

Official title:

The Performance Comparison of Two Oxygen Delivery Devices [Nasal Cannula and Mask] Used After General Anesthesia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917526
• Other study ID #: 066/2556 (EC3)
• Status: Completed
• Phase: N/A
• First received: August 5, 2013
• Last updated: June 25, 2015
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypoxemia

Intervention

Device:
• oxygen mask

• oxygen cannula

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidences of hypoxemia in both groups	Hypoxemia is defined as oxygen saturation < 94%	In PACU (1 hr after anesthesia)	Yes
Secondary	The causes of hypoxemia	Causes,treatment and outcome of hypoxemia in PACU will be recorded	In PACU (1 hr after anesthesia)	Yes