The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia
Primary Purpose
Pulmonary Atelectases, Lung Injury, General Anesthesia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
high-flow nasal oxygen
Oxygen mask
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Atelectases focused on measuring high flow oxygen, pulmonary atelectasis, intravenous general anesthesia
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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high-flow nasal oxygen
Oxygen mask
Arm Description
high-flow nasal oxygen was used during intravenous general anesthesia
oxygen mask was used during intravenous general anesthesia
Outcomes
Primary Outcome Measures
Chest CT image atelectatic area
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
postoperative pulmonary complications
postoperative pulmonary complications including pneumonia, pleural effusion, and acute lung injury.
lung injury
lung injury biomarkers including Clara cell protein, Plasma neutrophil elastase.
Full Information
NCT ID
NCT03019354
First Posted
January 10, 2017
Last Updated
May 28, 2018
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03019354
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectases, Lung Injury, General Anesthesia
Keywords
high flow oxygen, pulmonary atelectasis, intravenous general anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high-flow nasal oxygen
Arm Type
Experimental
Arm Description
high-flow nasal oxygen was used during intravenous general anesthesia
Arm Title
Oxygen mask
Arm Type
Active Comparator
Arm Description
oxygen mask was used during intravenous general anesthesia
Intervention Type
Device
Intervention Name(s)
high-flow nasal oxygen
Other Intervention Name(s)
High-flow nasal cannula
Intervention Description
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
Intervention Name(s)
Oxygen mask
Intervention Description
Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.
Primary Outcome Measure Information:
Title
Chest CT image atelectatic area
Description
lung atelectasis (-100 to +100 Hounsfield Unit) was calculated and as percent of the total area of the lung at the basal scan.
Time Frame
At the end of surgery
Secondary Outcome Measure Information:
Title
postoperative pulmonary complications
Description
postoperative pulmonary complications including pneumonia, pleural effusion, and acute lung injury.
Time Frame
within the first 7 days after surgery
Title
lung injury
Description
lung injury biomarkers including Clara cell protein, Plasma neutrophil elastase.
Time Frame
At the end of surgery
Other Pre-specified Outcome Measures:
Title
Respiratory gas exchange function
Description
blood gas analysis including PaO2, PaCO2
Time Frame
At the end of surgery
Title
need for supplemental oxygen therapy
Time Frame
within the first 7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chung-Chih Shih, MD
Phone
+886 911674300
Email
s6319138@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chung-Chih Shih, MD
Phone
+886 972653379
Email
s6319138@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu, MD,PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chung CHih SHih, MD
Phone
+886 972653379
Email
s6319138@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32890016
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.
Results Reference
derived
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The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia
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