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

NCT01917526 | Completed Results

• 1 other identifier: 066/2556 (EC3)
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

Oxygen; PACU; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• The Causes of Hypoxemia

  In PACU (1 hr after anesthesia)

Study Arms (2)

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.

Device: oxygen mask

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.

Device: oxygen cannula

Interventions

oxygen mask DEVICE

Also known as: Oxygen mask or simple mask

oxygen mask

oxygen cannula DEVICE

Oxygen cannula

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General anesthesia
• Age 18-70 years
• American Society of Anesthesiology (ASA)physical status 1-3
• Elective case

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Department of Anesthesiology, Siriraj Hospital
• Organization: Mahidol University

manee95@hotmail.com

66-2-41979889

Study Officials

• Manee Raksakietisak, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 6, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2016-11

Locations

TH (1)