NCT03874403

Anesthetic Component Research on VATS and NIVATS

Completed NA Last updated 8 October 2020

What this trial tests

NA trial testing DSA in Thoracoscopy in 60 participants. Completed in 30 September 2020.

Timeline

1 November 2018

Primary endpoint
2 October 2019

30 September 2020

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	60
Start date	1 November 2018
Primary completion	2 October 2019
Estimated completion	30 September 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• DSA

Conditions studied

• Thoracoscopy — all drugs for Thoracoscopy →
• Anesthesia; Functional — all drugs for Anesthesia; Functional →
• Tracheal Intubation — all drugs for Tracheal Intubation →

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Thoracoscopy or Anesthesia; Functional. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The non-intubated video-assisted thoracic surgery (NIVATS) can avoid intubation-related complications and for a smoother postoperative recovery. Successful results are accumulating not only from anecdotal case reports of difficult and high-risk patients not suitable for an intubated general anesthesia. However, in spite of safety and feasibility, there were still three main concerns: 1. how to maintain spontaneous breathing with optimal anesthetic depth; 2. How to analyze the components of general anesthesia and regional anesthesia; 3.what's the benefits on the recovery and the risk of aspiration risk with NIVATS? The traditional monitor or methods such as BIS system, SpO2, and follow-up aspiration signs could not offer sufficient evidence to resolve the three main concerns. Recently, there have been many new methods to monitor these concerns. The density spectral array (DSA) BIS system could analyze the change of the anesthetic component. The ORI is a dimensionless index that reflects oxygenation in the moderate hyperoxic range (PaO2 100-200 mmHg).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Contralateral spontaneous rupture of the esophagus following severe emesis after non-intubated pulmonary wedge resection.
   Liu L, Wu W, Gong L, Zhang M. · · 2020 · cited 1× · PMID 33004053 · DOI 10.1186/s13019-020-01321-w
2. Anesthetic Substitute of Intraoperative Regional Anesthesia of Nonintubated or Endotracheal-intubated Video-assisted Thoracoscopic Surgery With Thoracoscopic Multilevel Intercostal Nerve Blocks: a Randomized Study
   Chan K, Wu L, Han S, Chen J, et al · · 2021 · DOI 10.21203/rs.3.rs-690028/v1