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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: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03275428
Date of registration: 05/09/2017
Prospective Registration: Yes
Primary sponsor: Taipei Veterans General Hospital, Taiwan
Public title: THRIVE and Non-intubated Thoracic Surgery
Scientific title: Efficacy and Safety of Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) and Non-intubated Thoracic Surgery (NITS)
Date of first enrolment: September 11, 2017
Target sample size: 40
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT03275428
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Taiwan
Contacts
Name:     Chien-Kun Ting, MD, PhD
Address: 
Telephone: +886-938593137
Email: ckting@vghtpe.gov.tw
Affiliation: 
Name:     Chien-Kun Ting, MD, PhD
Address: 
Telephone: +886938593137
Email: ckting@vghtpe.gov.tw
Affiliation: 
Name:     Chien-Kun Ting, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Taipei Veterans General Hospital, Taiwan
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Thoracic Surgery
Oxygenation
Intervention(s)
Device: transnasal humidified rapid-insufflation ventilator exchange
Primary Outcome(s)
Arterial oxygen pressure [Time Frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.]
Arterial carbon dioxide pressure [Time Frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.]
Duration of stay [Time Frame: From admission to ward to discharge from ward, duration of 5 days to two weeks.]
Secondary Outcome(s)
Acute phase reaction [Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
TNF [Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
Interleukins [Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
Immune cell count [Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.]
Secondary ID(s)
2017-07-002B
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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