Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study

Launched by UNIVERSITY HOSPITAL, ROUEN · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying ways to prevent lung problems that can happen after thoracic surgery, where only one lung is used for breathing during the operation. When one lung is ventilated, the other lung can become compressed, leading to areas of the lung collapsing, which is called atelectasis. The researchers want to see if using specific techniques to open up these collapsed areas during surgery can help reduce lung complications after the surgery.

To participate in this trial, you need to be an adult between 18 and 75 years old who is scheduled for a lobectomy or segmentectomy (types of lung surgery) using video or robotic techniques. If you decide to join, you can expect to receive careful monitoring during surgery to detect any lung issues early. Depending on the findings, you may get additional supportive treatments after your surgery to help your recovery. It's important to note that certain individuals, such as those with specific lung diseases or other serious health conditions, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• • Adult patient aged 18 to 75 years inclusive
• • Patient requiring lobectomy or segmentectomy by video or robot-thoracoscopy
• • Patient having read and understood the information letter and signed the consent form
• • Patient affiliated to a social security system
• * Women :
• • Of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy))
• • using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device (IUD), male or female condoms) for at least 4 weeks before inclusion and during the study And,
• • Presenting a negative urine pregnancy test at inclusion;
• • Menopause: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
• Exclusion Criteria:
• • Patients aged 76 and over
• • COPD patients (Gold stage 3 or 4 of the 2023 Gold classification)
• • Patients with a history of ischemic coronary artery disease
• • Patients with a history of pulmonary emphysema bubbles on the ventilated lung
• • Tracheostomized patient
• • Obese patients (\>30 kg/m²)
• • Patients with a history of pulmonary resection
• • ASA patients ≥4
• • Patient benefiting from a pre-operative rehabilitation protocol with physiotherapy
• • Pregnant or parturient or breastfeeding woman or proven absence of contraception
• • Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship
• • History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent
• • Patient refusing to give consent.