Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03275428 |
Date of registration:
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05/09/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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THRIVE and Non-intubated Thoracic Surgery
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Scientific title:
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Efficacy and Safety of Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) and Non-intubated Thoracic Surgery (NITS) |
Date of first enrolment:
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September 11, 2017 |
Target sample size:
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40 |
Recruitment status: |
Not yet recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03275428 |
Study type:
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Observational |
Study design:
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chien-Kun Ting, MD, PhD |
Address:
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Telephone:
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+886-938593137 |
Email:
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ckting@vghtpe.gov.tw |
Affiliation:
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Name:
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Chien-Kun Ting, MD, PhD |
Address:
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Telephone:
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+886938593137 |
Email:
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ckting@vghtpe.gov.tw |
Affiliation:
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Name:
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Chien-Kun Ting, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Taipei Veterans General Hospital, Taiwan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Lung nodules requiring surgical resection
- Resectable by video-assisted thoracic surgery
Exclusion Criteria:
- ASA class IV or V
- Room air oxygen saturation by pulse oximeter < 90%
- Emergent surgery
- Use of inotropics or vasoconstrictors
- History of nasal surgery or cranial surgery
- Abnormal coagulation profile
- History of spinal surgery or trauma
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Thoracic Surgery
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Oxygenation
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Intervention(s)
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Device: transnasal humidified rapid-insufflation ventilator exchange
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Primary Outcome(s)
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Arterial oxygen pressure
[Time Frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.]
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Arterial carbon dioxide pressure
[Time Frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.]
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Duration of stay
[Time Frame: From admission to ward to discharge from ward, duration of 5 days to two weeks.]
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Secondary Outcome(s)
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Acute phase reaction
[Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
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TNF
[Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
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Interleukins
[Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
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Immune cell count
[Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
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Secondary ID(s)
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2017-07-002B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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