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

Not Applicable

• Conditions: Lung Injury; Pulmonary Atelectases; General Anesthesia

• Registration Number: NCT03019354
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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)

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-05-30
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Chest CT image atelectatic area	At the end of surgery	lung atelectasis (-100 to +100 Hounsfield Unit) was calculated and as percent of the total area of the lung at the basal scan.

Secondary Outcome Measures

Name	Time	Method
lung injury	At the end of surgery	lung injury biomarkers including Clara cell protein, Plasma neutrophil elastase.
postoperative pulmonary complications	within the first 7 days after surgery	postoperative pulmonary complications including pneumonia, pleural effusion, and acute lung injury.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan