One-Lung Ventilation Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 192 |
Est. completion date | June 25, 2024 |
Est. primary completion date | June 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: A - pre-operative 1. anticipated difficult intubation 2. New York Heart Association (NYHA) heart failure class III/IV 3. body mass index=35kg/m2 4. patients with abnormal expiratory recoil [forced expiratory volume in 1s (FEV1) less than 70% of predicted values 5. chronic obstructive pulmonary disease (COPD) or severe asthma 6. prior thoracic surgery or radiotherapy 7. a history of pleural or interstitial disease B - post-randomization 1. the discovery of pleural adhesions following pleural opening 2. a delay of more than 25 minutes between the onset of one-lung ventilation and chest opening 3. the duration between the onset of one-lung ventilation and chest opening less than 10 minutes 4. a switch to thoracotomy as the type of surgical procedure 5. he occurrence of significant adverse events during the operation, such as severe bleeding (more than 1500ml), fatal arrhythmia, respiratory arrest, or cardiac arrest |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sichuan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | The first 24 hours after surgery | |
Secondary | 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. | Up to the end of the thoracoscopic surgery | |
Secondary | 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. | Up to the end of the thoracoscopic surgery | |
Secondary | 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. | During hospital stay, an expected average of one week |
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