Compared Unidirectional Valve Apparatus and Occluding the Non-ventilated Endobronchial Lumen for Lung Collapse.

NCT06210256 | Unknown

• 1 other identifier: 2023HXFH012
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

With the rapid advancement of thoracoscopic surgery in recent years, surgeons have set higher standards for the quality of non-ventilated lung collapse. In a prior investigation, we examined a unidirectional valve device that let air exit the non-ventilated side of the lung but not enter during ventilation and showed the use of this device during one-lung ventilation (OLV) for patients undergoing thoracoscopic surgery could speed up lung collapse, lower endogenous positive end-expiratory pressure, and have no discernible effects on oxygenation. In light of this, we conducted this study to further demonstrate, by comparison with the commonly used clinical technique of occluding the non-ventilated endobronchial lumen during one-lung ventilation, that this unidirectional valve device can quicken and enhance the quality of lung collapse without raising the risk of adverse events when used in thoracoscopic surgery.

Conditions

Video-assisted Thoracoscopic Surgery; One-Lung Ventilation

Outcome Measures

Primary Outcomes (1)

• The time needed for satisfactory lung collapse

  The outcome was measured from the initial of one-lung ventilation after clamping the non-ventilated lumen of DLT to the time of satisfactory lung collapse, graded via video view, by an independent investigator who was blinded to the lung collapse technique using a verbal analogue scale (0 = no lung collapse; 10 = total lung collapse). A score of eight for satisfactory lung collapse meant that the lung tissue had essentially collapsed, the surgical field was clearly visible, and the surgeons could carry out routine procedures.

  The first 24 hours after surgery

Secondary Outcomes (4)

• The quality of lung collapse

  The first 24 hours after surgery

• The need for bronchial suction

  Up to the end of the thoracoscopic surgery

• The development of intraoperative hypoxemia

  Up to the end of the thoracoscopic surgery

• The incidence of postoperative pulmonary complications

  During hospital stay, an expected average of one week

Study Arms (2)

the unidirectional valve group

EXPERIMENTAL

In the unidirectional valve group, as soon as disinfection and draping began, the lumen of the Y-connector to the non-ventilated lung was clamped and the unidirectional valve device was fastened to the bronchoscope port of the tracheal lumen to initial the one-lung ventilation.

Procedure: unidirectional valve apparatus

the closed lumen group

ACTIVE COMPARATOR

In the closed lumen group, as soon as disinfection and draping began, the lumen of the Y-connector to the non-ventilated lung was clamped, and the bronchoscope port of the tracheal lumen was sealed off from the atmosphere until pleural opening. When the pleura opened, the bronchoscope port opened to the air for 30 seconds before closing once more until the one-lung ventilation was completed.

Procedure: occluding the non-ventilated endobronchial lumen

Interventions

unidirectional valve apparatus PROCEDURE

In the unidirectional valve group, we attached the unidirectional valve device to the lumen's distal port when one-lung ventilation initiated.

the unidirectional valve group

occluding the non-ventilated endobronchial lumen PROCEDURE

In the closed operative lumen group, we closed the lumen's distal port of non-ventilated lung when one-lung ventilation initiated.

the closed lumen group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old
• American Society of Anesthesiologists (ASA) physical status I to III
• Patients scheduled to undergo video-associated thoracoscopic surgery requiring one-lung ventilation

You may not qualify if:

• A - pre-operative
• anticipated difficult intubation
• New York Heart Association (NYHA) heart failure class III/IV
• body mass index≥35kg/m2
• patients with abnormal expiratory recoil \[forced expiratory volume in 1s (FEV1) less than 70% of predicted values
• chronic obstructive pulmonary disease (COPD) or severe asthma
• prior thoracic surgery or radiotherapy
• a history of pleural or interstitial disease
• B - post-randomization
• the discovery of pleural adhesions following pleural opening
• a delay of more than 25 minutes between the onset of one-lung ventilation and chest opening
• the duration between the onset of one-lung ventilation and chest opening less than 10 minutes
• a switch to thoracotomy as the type of surgical procedure
• he occurrence of significant adverse events during the operation, such as severe bleeding (more than 1500ml), fatal arrhythmia, respiratory arrest, or cardiac arrest

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Study Officials

• Peng Liang, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Peng Liang, PhD

CONTACT

18980602201; liangpengwch@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To guarantee the blinding of the surgeons and data recorders, a cover was placed over the patient's head and the DLT connector during the surgical operation. An independent investigator, who blinded to treatment assignment, carried out the postoperative assessment of lung collapse quality and subsequent follow-up visits. The anesthesiologist, who performed the DLT intubation, was the only study personnel unblinded to the randomization scheme and was not involved in data collection and analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 18, 2024
• Study Start: January 25, 2024
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)