N/A
N=78
Nitrous Oxide for Identifying the Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
Pulmonary Nodule, Solitary · Pulmonary Nodule, Multiple · Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04302350 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: The Intersegmental Border Appearance Time During the Surgery — 320.20; 552.39; 968.33 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nitrous oxide (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Intersegmental Border Appearance Time During the Surgery |
320.20; 552.39; 968.33 | — |
Summary
Lung cancer is currently one of the most common malignant tumors in the world. In recent years, with the popularity of high-resolution CT, more and more early-stage lung cancers have been found. Anatomic pneumonectomy is gradually popular because it can completely remove lung nodules and preserve lung function to the greatest extent. During the surgery, the precise and rapid determination of intersegmental border is one of the key technologies. Improved inflation-deflation method is currently the most widely used method in clinical practice. Previous studies demonstrated that increasing the concentration of nitrous oxide in mixtures of N2O/O2 will lead to a faster rate of collapse. The rapid diffusion properties of N2O would be expected to speed lung collapse and so facilitate surgery. This study was designed to explore three types of inspired gas mixture used during two-lung anesthesia had an effect on the intersegmental border appearance time during pneumonectomy and its feasibility and safety: 75% N2O (O2: N2O = 1: 3), 50% N2O (O2: N2O = 1: 1), 100% oxygen.
Eligibility Criteria
Inclusion Criteria
1、20 to 70 years of age; 2、early stage lung cancer（diameter of tumor consolidation ≤ 2cm, none evidence of lymph node or distant metas-tasis, c-stage ⅠA1 or ⅠA2）（active limited resection）； 3、 patients at high risk due to poor general condition who cannot undergo lobectomy (c-stage IA1 to IA3) (passive limited resection)
Exclusion Criteria
- a history of severe asthma or pneumothorax；
- pulmonary bullae on chest CT；
- patient refusal
Data sourced from ClinicalTrials.gov (NCT04302350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.