Clinical trial NCT04302350: Nitrous Oxide for Identifying the Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
Official title: Nitrous Oxide for Identifying the Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Lung Cancer
Keywords: pulmonary nodule
lung cancer
nitrous oxide
thoracoscopic anatomic segmentectomy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This randomized parallel group trial enrolled lung cancer patients scheduled to receive thoracoscopic anatomic segmentectomy at The First Affiliated Hospital of Nanjing Medical University. When anesthesia induction was completed, intubation was carried out using an appropriate-size double-lumen endobronchial tube (DLT) and the position of the DLT was confirmed with fiberoptic bronchoscopy and adjusted as needed. OLV of the dependent lung with FiO2=1.0 was begun in the lateral position, by clamping the DLT to the nonventilated lung proximally and opening the distal port of the DLT lumen to the atmosphere. Tidal volumes were 5 mL/kg ideal bodyweight (male: height -100, and female: height - 105) without positive end expiratory pressure (PEEP). In order to avoid possible confounding effects of inhalation of volatile anesthetics on oxygenation, all subjects received total intravenous anesthesia.

According to preoperative 3D-CTBA evaluation of bronchial and vascular structure of pulmonary nodules and pulmonary segments, the target segmental bronchus, arteries and intra-segment veins were accurately identi-fied and dissected by ligation or stapler cutting. After that, the anesthesiologist began to make preparations for the lung inflation. The portable nitrous oxide concentration detector (TD600-SH-B-N2O) was installed to detect N2O concentration (vol%), and then adjusted the anesthesia machine to the manual control mode. The flow of the selected gas mixture was set to 8L/min (Group75 set to N2O:O2=6:2, Group50 set to N2O:O2=4:4, Group0 set to O2=8), avoiding the interference of the total gas flow. When the N2O concentration detector reached the predetermined gas concentration, and then the collapsed lung was re-expanded completely with controlled airway pressure under 20 cmH2O (1cm H2O=0.098 kPa) by the anesthesiologist. This procedure took approximately 1 min, and then FiO2=1.0 was performed after the initiation of the OLV.

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:

1. a history of severe asthma or pneumothorax；
2. pulmonary bullae on chest CT；
3. patient refusal

Primary outcomes:
measure: The Intersegmental Border Appearance Time During the Surgery
timeFrame: The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons
Secondary outcomes:
Other outcomes:
measure: The Incidence of Postoperative Complications and the Length of Hospital Stay
timeFrame: 2 weeks after surgery.
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: cunming liu, Master
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: quan zhu, Doctorate
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: shijiang liu, Attending physician
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: wenjing yang, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: zicheng liu, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wei Wen, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jun Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: