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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03275428
Other study ID # 2017-07-002B
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 5, 2017
Last updated September 6, 2017
Start date September 11, 2017
Est. completion date September 10, 2018

Study information

Verified date August 2017
Source Taipei Veterans General Hospital, Taiwan
Contact Chien-Kun Ting, MD, PhD
Phone +886-938593137
Email ckting@vghtpe.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Video assisted thoracic surgery utilizes small instruments to perform complicated thoracic surgeries. This minimally invasive technique leaves small wounds thus facilitate recovery. Traditionally, thoracic surgery required general anesthesia with double lumen endobronchial tube to facilitate one-lung ventilation. However, as anesthesia techniques improve, video assisted thoracic surgery can be achieved with minimal sedation and without intubation. Thoracic surgeries involve excision of lung tissue thus impair post-operative lung function, putting patients at high risk of cardiopulmonary complications. Non-intubate thoracic surgeries can avoid this complication by avoiding general anesthesia and intubation.

Transnasal humidified rapid-insufflation ventilator exchange offers 30-50 L/min oxygen via nasal cannula, thus provide safe and comfortable way of oxygen supplementation. It is useful in intravenous sedated patients since they are prone to hypoxia from respiratory suppression and upper airway obstruction.

This study is a matched case-control study to compare the efficacy and safety of Transnasal humidified rapid-insufflation ventilator exchange in non-intubated thoracic surgery versus double lumen endobronchial tube intubated general anesthesia.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
transnasal humidified rapid-insufflation ventilator exchange
high flow nasal cannula with humidified oxygen

Locations

Country Name City State
Taiwan Department of Anesthesiology, Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial oxygen pressure Capability of maintaining arterial oxygen pressure > 100 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room. From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.
Primary Arterial carbon dioxide pressure Capability of maintaining arterial carbon dioxide pressure < 50 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room. From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours.
Primary Duration of stay Duration of stay as in days of admission in the hospital From admission to ward to discharge from ward, duration of 5 days to two weeks.
Secondary Acute phase reaction Measure of C-reactive protein from blood sample analysis before anesthetic induction, after tumor resection during surgery, on post-operative day 1, 3 and 5. From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
Secondary Interleukins Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery, on post-operative day 1, 3 and 5. From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
Secondary TNF Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery, From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
Secondary Immune cell count Measure of Immune cell count from blood sample analysis before anesthetic induction, after tumor resection during surgery, From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.
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