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Video-assisted Thoracoscopic SurgeryNCT06210256

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

A study testing unidirectional valve apparatus and occluding the non-ventilated endobronchial lumen in people with Video-assisted Thoracoscopic Surgery and One-Lung Ventilation, run by Sichuan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
unidirectional valve apparatus and occluding the non-ventilated endobronchial lumen
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteChina
Study dates
25 Jan 2024to 25 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Peng Liang, PhD contact

18980602201

liangpengwch@scu.edu.cn

China1 site
  • West China Hospital

    Chengdu, Sichuan, 610041

    Peng Liang, PhD, 18980602201, liangpengwch@scu.edu.cn

Other trials in China

About this study

Official title: A Comparison of Unidirectional Valve Apparatus With Occluding the Non-ventilated Endobronchial Lumen for Lung Collapse During Video-associated Thoracoscopy: a Prospective Randomized Controlled Trial.

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.

Read the detailed description

In this study, patients who meet the enrollment criteria will be randomized 1:1 to the unidirectional valve group or the closed lumen group.

After patients entered the operating room, their heart rate, mean arterial pressure, electrocardiogram, and pulse oxygen saturation were monitored. The electrodes of a bispectral index (BIS) Vista monitor were placed on the patient's forehead. The mask for oxygen inhalation at 6 L/min was then applied. Anesthesia was induced with 2mg midazolam, 0.3ug/kg sufentanil, 2-3mg/kg propofol and 0.3mg/kg cisatracurium using ideal body weight. Patients were intubated using a video double-lumen endotracheal tube [Disposable sterile double-lumen tracheal intubation, Nortier] by a senior anesthesiologist. Following confirmation of the double-lumen tube (DLT) placement position, two-lung ventilation was started at a respiratory rate of 15 breaths per minute, with an inspiratory to expiratory (I: E) ratio of 1:2, tidal volume of 8 ml/kg, and an inspired oxygen fraction (FiO2) of 0.8. Remifentanil (0.05-0.3 ug/kg/min) and propofol (4-12 mg/kg/h) were continuously infused to maintain anesthesia while the levels of BIS fluctuated between 40 and 60. The DLT placement location was verified again as soon as the disinfection and draping process started, and one-lung ventilation was initiated. In this study, we used a disposable plastic membrane glove and chopped off the fingers to create a unidirectional valve device. Our prior clinical experiment showed that this device permits gas in the non-ventilated lung to exit during exhalation, while ambient air could not enter via the collapsed cut hole during inhalation. 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. 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. The tidal volume was adjusted to 6 ml/kg during OLV, and the respiratory rate was set to 15 breaths per minute with a I:E ratio of 1:2 and FiO2 of 0.8. Positive expiratory pressure was not applied in this trial. After pleural opening, the thoracoscopic surgery procedure was captured on video using an electronic equipment. The anesthesiologist, who was blind to the specific lung collapse technique, watched the recordings after surgery and used a visual analogue scale to assess the quality of lung collapse at various time points. Bronchial suction was employed to foster lung collapse of the non-ventilated lung if there was no collapse or partial collapse of the lung during the surgical procedure. The number and timing of bronchial suction should be documented in detail. After surgery, patients were transferred to the post-anesthesia care unit (PACU) for continued monitoring. Throughout their hospital stay, the patients were visited daily, and any postoperative pulmonary issues were recorded in time until the patients were released from the hospital.

Being tested
unidirectional valve apparatus, occluding the non-ventilated endobronchial lumen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • unidirectional valve apparatusProcedure or surgery

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

  • occluding the non-ventilated endobronchial lumenProcedure or surgery

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

Study groups in NCT06210256
Study groupRoleWhat they receive
the unidirectional valve groupExperimentalIn 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.
Receives: Procedure: unidirectional valve apparatus
the closed lumen groupActive comparatorIn 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.
Receives: Procedure: occluding the non-ventilated endobronchial lumen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: The first 24 hours after surgery

Secondary outcomes (4)
  1. The quality of lung collapse

    An independent investigator viewed the video and scored the quality of lung collapse upon entering the thoracic cavity, and at 5, 10, 15, and 20 min following pleural opening using a verbal rating scale from zero to ten (0 = no lung collapse; 10 = total lung collapse).

    Measured: The first 24 hours after surgery

  2. The need for bronchial suction

    If there was no collapse or just partial collapse of the lung during the surgical procedure and it hindered the surgical operation, bronchial suction was used to promote lung collapse of the non-ventilated lung.

    Measured: Up to the end of the thoracoscopic surgery

  3. The development of intraoperative hypoxemia

    The development of intraoperative hypoxemia was defined as a decrease in peripheral blood oxygen saturation (SpO2) below 90% during surgical procedure.

    Measured: Up to the end of the thoracoscopic surgery

  4. The incidence of postoperative pulmonary complications

    The patients developed one or more of the following postoperative pulmonary complications during hospitalization: respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.

    Measured: During hospital stay, an expected average of one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start25 Jan 2024 (estimated)
  3. Primary completion25 Jun 2024 (estimated)
  4. Study completion25 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06210256
Sponsor's protocol ID
2023HXFH012
Status last verified
Jan 2024
First submitted
4 Jan 2024
Last updated
18 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing unidirectional valve apparatus and occluding the non-ventilated endobronchial lumen in people with Video-assisted Thoracoscopic Surgery and One-Lung Ventilation, run by Sichuan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peng Liang, PhD (18980602201, liangpengwch@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time needed for satisfactory lung collapse (time frame: The first 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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