The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia

NCT ID: NCT03019354

Last Updated: 2018-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

Brief Summary

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In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It has physiological effects: reduction of anatomical dead space, positive end expiratory pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia could improve lung function and prevent lung atelectasis.

Detailed Description

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After general anesthesia, almost 90% patients have lung atelectasis. The lung atelectasis persisted even after the surgery, and caused post operative complication, for example: fever, pleural effusion, hypoxemia, pneumonia, and respiratory failure. So, how to improve lung function after the surgery is a important issue. High-flow nasal cannula oxygen therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It provides respiratory support: 1. Reduction of dead Space by clearance of expired air in the upper airways. 2. Delivering positive airway pressure. 3. delivering optimal humidity, which helps maintain function of the mucociliary transport system, clearing secretions and reducing the risk of infections. Many reports suggest that high-flow nasal cannula decreases breathing frequency and work of breathing and reduces intubation rate in critical ill patients. Although high-flow nasal cannula was used widely in intensive care unit (ICU) , there are no enough evidence in patients under general anesthesia. The hypothesis of this study is that using high-flow nasal oxygen in intravenous general anesthesia could improve lung function and prevent lung atelectasis. Liver tumor radiofrequency ablation was performed sometimes in patients under general anesthesia. Intravenous general anesthesia is one of the anesthesia choice. Oxygen mask is the traditional oxygen delivery system. Apnea, hypoxemia, and CO2 retention are common situation in intravenous general anesthesia. So high-flow nasal oxygen is an ideal oxygen delivery system in intravenous general anesthesia. This randomized control study will enroll patients receiving CT guided liver tumor radiofrequency ablation under general anesthesia. One group will receive high-flow nasal oxygen, the other group will receive traditional oxygen mask. The primary outcome is lung atelectasis area in CT scan. The secondary outcome is respiratory function (for example: arterial blood gas, lung injury biomarkers, saturation, postoperative pulmonary complication)

Conditions

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Pulmonary Atelectases Lung Injury General Anesthesia

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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high-flow nasal oxygen

high-flow nasal oxygen was used during intravenous general anesthesia

Group Type EXPERIMENTAL

high-flow nasal oxygen

Intervention Type DEVICE

Using high-flow nasal oxygen 10 L/min before anesthesia induction, then using high-flow nasal oxygen 30-50 L/min during intravenous general anesthesia.

Oxygen mask

oxygen mask was used during intravenous general anesthesia

Group Type ACTIVE_COMPARATOR

Oxygen mask

Intervention Type DEVICE

Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.

Interventions

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high-flow nasal oxygen

Using high-flow nasal oxygen 10 L/min before anesthesia induction, then using high-flow nasal oxygen 30-50 L/min during intravenous general anesthesia.

Intervention Type DEVICE

Oxygen mask

Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.

Intervention Type DEVICE

Other Intervention Names

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High-flow nasal cannula

Eligibility Criteria

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Inclusion Criteria

* Patients with hepatic tumor undergoing CT guided radiofrequency ablation
* Age \> 20 years old

Exclusion Criteria

* Cardiac dysfunction, such as heart failure \> NYHA class II, coronary arterial disease
* Impaired renal function, cGFR\< 60 ml/min/1.73 m2
* Pulmonary disease
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Yu Wu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chung-Chih Shih, MD

Role: CONTACT

+886 911674300

Chung-Chih Shih, MD

Role: CONTACT

+886 972653379

Facility Contacts

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Chung CHih SHih, MD

Role: primary

+886 972653379

References

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Shih CC, Liang PC, Chuang YH, Huang YJ, Lin PJ, Wu CY. Effects of high-flow nasal oxygen during prolonged deep sedation on postprocedural atelectasis: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):1025-1031. doi: 10.1097/EJA.0000000000001324.

Reference Type DERIVED
PMID: 32890016 (View on PubMed)

Other Identifiers

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201611036RIN

Identifier Type: -

Identifier Source: org_study_id

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