NCT03275428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

September 7, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

September 5, 2017

Last Update Submit

September 6, 2017

Conditions

Thoracic SurgeryOxygenation

Keywords

THRIVENon-intubated thoracic surgery

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (4)

  • Acute phase reaction

    From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.

  • Interleukins

    From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.

  • TNF

    From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.

  • Immune cell count

    From induction of anesthesia to surgical procedure to fifth post-operative day, duration of six days.

Study Arms (2)

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

Double lumen group

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

Interventions

transnasal humidified rapid-insufflation ventilator exchangeDEVICE

high flow nasal cannula with humidified oxygen

THRIVE group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lung nodules requiring surgical resection

You may qualify if:

  • Lung nodules requiring surgical resection
  • Resectable by video-assisted thoracic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Study Officials

  • Chien-Kun Ting, MD, PhD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Kun Ting, MD, PhD

CONTACT

+886-938593137ckting@vghtpe.gov.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 7, 2017

Study Start

September 11, 2017

Primary Completion

September 10, 2018

Study Completion

September 10, 2018

Last Updated

September 7, 2017

Record last verified: 2017-08

Locations

TW(1)