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THRIVE and Non-intubated Thoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03275428
Recruitment Status : Unknown
Verified August 2017 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.


Condition or disease Intervention/treatment
Thoracic Surgery Oxygenation Device: transnasal humidified rapid-insufflation ventilator exchange

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Efficacy and Safety of Transnasal Humidified Rapid-insufflation Ventilator Exchange (THRIVE) and Non-intubated Thoracic Surgery (NITS)
Estimated Study Start Date : September 11, 2017
Estimated Primary Completion Date : September 10, 2018
Estimated Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
THRIVE group
Patients receiving non-intubated thoracic surgery for lung nodule resections using intravenous sedation and transnasal humidified rapid-insufflation ventilator exchange
Device: transnasal humidified rapid-insufflation ventilator exchange
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



Primary Outcome Measures :
  1. Arterial oxygen pressure [ Time Frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours. ]
    Capability of maintaining arterial oxygen pressure > 100 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room.

  2. Arterial carbon dioxide pressure [ Time Frame: From induction of anesthesia to surgical procedure to end of recovery room observation, duration of six hours. ]
    Capability of maintaining arterial carbon dioxide pressure < 50 mmHg from arterial blood gas analysis before anesthetic induction, during surgery and in recovery room.

  3. Duration of stay [ Time Frame: From admission to ward to discharge from ward, duration of 5 days to two weeks. ]
    Duration of stay as in days of admission in the hospital


Secondary Outcome Measures :
  1. Acute phase reaction [ Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days. ]
    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.

  2. Interleukins [ Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days. ]
    Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery, on post-operative day 1, 3 and 5.

  3. TNF [ Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days. ]
    Measure of interleukins from blood sample analysis before anesthetic induction, after tumor resection during surgery,

  4. Immune cell count [ Time Frame: From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days. ]
    Measure of Immune cell count from blood sample analysis before anesthetic induction, after tumor resection during surgery,



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lung nodules requiring surgical resection
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275428


Contacts
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Contact: Chien-Kun Ting, MD, PhD +886-938593137 ckting@vghtpe.gov.tw

Locations
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Taiwan
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, Taiwan, 112
Contact: Chien-Kun Ting, MD, PhD    +886938593137    ckting@vghtpe.gov.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Chien-Kun Ting, MD, PhD Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03275428    
Other Study ID Numbers: 2017-07-002B
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
THRIVE
Non-intubated thoracic surgery
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action