THRIVE and Non-intubated Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

Efficacy and Safety of Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) and Non-intubated Thoracic Surgery (NITS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03275428
• Other study ID #: 2017-07-002B
• 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
• 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:

Lung cancer has been a leading cause of death for years. There are more than 10,000 new cases in Taiwan. Delayed discovery of the disease is a reason for high mortality rate. Most cases are discovered after second stage. Early discovery of the disease rely on low dose CT scans. Early stage lung cancer patients are candidates for minimally invasive surgeries. Traditionally thoracomies and video-assisted thoracic surgeries require general anesthesia with double lumen endobronchial tubes. The technique of double lumen intubation and one lung ventilation causes respiratory complications and damage to the trachea, larynx and vocal cords. With the development of single port thoracotomies, anesthesia can be minimized as well. Patients receive an epidural, intercostal or paravertebral nerve block to decrease pain. Minimal anesthetic agents may be given to decrease anxiety or to induce light sedation. Patients does not need to be intubated and can maintain respiratory function and can recover quickly.

Not only can video-assisted thoracic surgery be used in lung tumor treatment, it can also be used to threat esophageal and mediastinal lesions, pneumothorax or as a diagnostic tool. Video-assisted thoracic surgery was shown to decrease acute phase inflammatory reactions, decrease immunosuppression and can be beneficial for tumor treatment.

The intravenous sedation medications used in non-intubate thoracic surgery decrease pain and anxiety. However, many will develop respiratory depression and upper airway obstruction. Also, spontaneous pneumothorax during surgery causes one lung ventilation. Traditional oxygen supply cannot meet the demand of non-intubated thoracic surgery. Transnasal humidified rapid-insufflation ventilator exchange offers 30-70 L/min oxygen via nasal cannula. Its humidified oxygen can decrease discomfort from cold dry gas. It also provides positive pressure to the airway thus decrease airway obstruction.

Our hypothesis is that non-intubated thoracic surgery with transnasal humidified rapid-insufflation ventilator exchange can maintain optimal surgical condition such as maintain arterial oxygen pressure, decrease acute phase reactions, tumor suppression and accelerate recovery after surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxygenation
• Thoracic Surgery

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.