Nitrous Oxide for Identifying the Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial

NCT04302350 | Completed Results

• 1 other identifier: 2019-SR-449
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple; Lung Cancer

Keywords

pulmonary nodule; lung cancer; nitrous oxide; thoracoscopic anatomic segmentectomy

Outcome Measures

Primary Outcomes (1)

• The Intersegmental Border Appearance Time During the Surgery

  The starting point of intraoperative expansion and collapse observation is the time when the lung tissue is completely expanded after blocking the relevant structure of the target segment; the end point is when a clear demarcation is formed between the target segment and the immediately-reserved lung segment, and this boundary does not follow significant changes over time), and the time was recorded in seconds (S).

  The time of appearance of the intersegmental plane that can be performed satisfactorily by surgeons

Other Outcomes (1)

• The Incidence of Postoperative Complications and the Length of Hospital Stay

  2 weeks after surgery.

Study Arms (3)

Group75

EXPERIMENTAL

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 identified 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). 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.

Procedure: nitrous oxide

Group50

EXPERIMENTAL

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 identified 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 (Group50 set to N2O:O2=4:4). 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.

Procedure: nitrous oxide

Group0

ACTIVE COMPARATOR

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 identified 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 (Group0 set to O2=8). 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.

Procedure: nitrous oxide

Interventions

nitrous oxide PROCEDURE

During one-lung ventilation with an open chest, the nonventilated lung collapses initially due to elastic recoil, which quickly brings the lung down to its closing capacity. Remaining gas in the lung is then removed by absorption into the pulmonary capillary blood. The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.

Also known as: oxygen

Group0; Group50; Group75

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 、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)

You may not qualify if:

• a history of severe asthma or pneumothorax；
• pulmonary bullae on chest CT；
• patient refusal

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules; Lung Neoplasms

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Results Point of Contact

• Title: Dr.cunming Liu
• Organization: The First Affiliated Hospital of Nanjing Medical University

cunmingliu@njmu.edu.cn

13951890866

Study Officials

• cunming liu, Master

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• quan zhu, Doctorate

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

• shijiang liu, Attending physician

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

• wenjing yang, Master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• zicheng liu, Doctorate

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Wei Wen, Master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Jun Wang, Master

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor of The department of anaesthesiology and perioperate

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 10, 2020
• Study Start: January 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: March 2, 2023
• Results First Posted: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)