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

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ClinicalTrials.gov Identifier: NCT03019354
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Atelectases Lung Injury General Anesthesia Device: high-flow nasal oxygen Device: Oxygen mask Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: high-flow nasal oxygen
high-flow nasal oxygen was used during intravenous general anesthesia
Device: 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.
Other Name: High-flow nasal cannula

Active Comparator: Oxygen mask
oxygen mask was used during intravenous general anesthesia
Device: Oxygen mask
Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.




Primary Outcome Measures :
  1. Chest CT image atelectatic area [ Time Frame: 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 :
  1. postoperative pulmonary complications [ Time Frame: within the first 7 days after surgery ]
    postoperative pulmonary complications including pneumonia, pleural effusion, and acute lung injury.

  2. lung injury [ Time Frame: At the end of surgery ]
    lung injury biomarkers including Clara cell protein, Plasma neutrophil elastase.


Other Outcome Measures:
  1. Respiratory gas exchange function [ Time Frame: At the end of surgery ]
    blood gas analysis including PaO2, PaCO2

  2. need for supplemental oxygen therapy [ Time Frame: within the first 7 days after surgery ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019354


Contacts
Contact: Chung-Chih Shih, MD +886 911674300 s6319138@gmail.com
Contact: Chung-Chih Shih, MD +886 972653379 s6319138@hotmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10048
Contact: Chung CHih SHih, MD    +886 972653379    s6319138@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chun-Yu Wu, MD,PhD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03019354     History of Changes
Other Study ID Numbers: 201611036RIN
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Taiwan University Hospital:
high flow oxygen
pulmonary atelectasis
intravenous general anesthesia

Additional relevant MeSH terms:
Lung Injury
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs