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

NCT ID: NCT01917526

Last Updated: 2017-01-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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oxygen mask

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.

Group Type ACTIVE_COMPARATOR

oxygen mask

Intervention Type DEVICE

Oxygen cannula

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.

Group Type ACTIVE_COMPARATOR

oxygen cannula

Intervention Type DEVICE

Interventions

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oxygen mask

Intervention Type DEVICE

oxygen cannula

Intervention Type DEVICE

Other Intervention Names

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Oxygen mask or simple mask

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manee Raksakietisak, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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066/2556 (EC3)

Identifier Type: -

Identifier Source: org_study_id

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