Clinical trial NCT03019354: The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia
Official title: The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Atelectases
Lung Injury
General Anesthesia
Keywords: high flow oxygen
pulmonary atelectasis
intravenous general anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Chest CT image atelectatic area
timeFrame: At the end of surgery
Secondary outcomes:
measure: postoperative pulmonary complications
timeFrame: within the first 7 days after surgery
measure: lung injury
timeFrame: At the end of surgery
Other outcomes:
measure: Respiratory gas exchange function
timeFrame: At the end of surgery
measure: need for supplemental oxygen therapy
timeFrame: within the first 7 days after surgery
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.