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OpenTrials
Completed

NCT Number: NCT01917526

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj hospital

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen Mask

Device

Other names: Oxygen mask or simple mask

oxygen cannula

Device

Primary outcomes

  1. Number of Participants With Hypoxemia in Both Groups

    Time frame: In PACU (1 hr after anesthesia)

    Hypoxemia is defined as oxygen saturation < 94%. We record number of participants with hypoxemia in both groups

Secondary outcomes

  1. The Causes of Hypoxemia

    Time frame: In PACU (1 hr after anesthesia)

    Causes of hypoxemia in each participant in PACU will be recorded

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2013
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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