THRIVE and Non-intubated Thoracic Surgery

NCT ID: NCT03275428

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2018-09-10

Brief 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.

Detailed 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.

Conditions

Thoracic Surgery; Oxygenation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

THRIVE group

Patients receiving non-intubated thoracic surgery for lung nodule resections using intravenous sedation and transnasal humidified rapid-insufflation ventilator exchange

transnasal humidified rapid-insufflation ventilator exchange

Intervention Type: DEVICE

high flow nasal cannula with humidified oxygen

Double lumen group

Patients receiving non-intubated thoracic surgery for lung nodule resections using general anesthesia and double lumen endobronchial tube

No interventions assigned to this group

Interventions

transnasal humidified rapid-insufflation ventilator exchange

high flow nasal cannula with humidified oxygen

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Kun Ting, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Chien-Kun Ting, MD, PhD

Role: CONTACT

ckting@vghtpe.gov.tw

+886-938593137

Facility Contacts

Chien-Kun Ting, MD, PhD

Role: primary

ckting@vghtpe.gov.tw

+886938593137

Other Identifiers

2017-07-002B

Identifier Type: -

Identifier Source: org_study_id