One Lung Ventillation (OLV)
Conditions
Keywords
robot-assisted esophagectomy, double-lumen endobronchial tube, bronchial blocker, vocal cord palsy
Brief summary
The goal of this clinical trial is to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.
Detailed description
Esophagectomy is a challenging surgery that usually requires one lung ventilation, and double-lumen endobronchial tubes and bronchial blockers are commonly used for one lung ventilation. Successful resection of recurrent laryngeal nerve lymph nodes during esophagectomy is important to survival and prevention of cancer recurrence, but there is a risk of postoperative vocal cord palsy due to the recurrent laryngeal nerve injury during the resection. Compared to a double-lumen endobronchial tube, the use of a bronchial blocker is expected to reduce the incidence of recurrent laryngeal nerve injury; however, few clinical studies compare the two devices in terms of the incidence of postoperative vocal cord palsy in robot-assisted esophagectomy. Therefore, the researchers aimed to investigate whether the use of bronchial blocker could reduce the incidence of postoperative vocal cord palsy than the use of double-lumen endobronchial tube in robot-assisted esophagectomy.
Interventions
DEVICEbronchial blocker
Lung isolation for robot-assisted esophagectomy will be performed using bronchial blocker in this group.
DEVICEdouble-lumen endobronchial tube
Lung isolation for robot-assisted esophagectomy will be performed using double-lumen endobronchial tube in this group.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 19 or older * American Society of Anesthesiologists physical status I - III * Elective robot-assisted esophagectomy * Any clinical stage of esophageal cancer * Patients who need recurrent laryngeal nerve lymph nodes resection
Exclusion criteria
* Patients who diagnosed vocal cord palsy or damage before surgery * Patients who need specific airway device due to airway problem * History of thoracic surgery * Emergency surgery * Combined surgery with other department * Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative vocal cord palsy | On postoperative day 7 after robot-assisted esophagectomy | On postoperative day 7, ENT doctor will performed the laryngoscopy exam to check the presence of vocal cord palsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of resected recurrent laryngeal nerve lymph nodes | At the end of surgery | Number of successfully resected recurrent laryngeal nerve lymph nodes will be counted at the end of surgery |
| Quality of one lung ventilation | during one lung ventilation | during one lung ventilation, anesthesiologists will evaluate the degree (excellent, fair, poor) of lung collapse. |
| Surgical difficulty reported by surgeon | At the end of surgery | Surgeon will report the surgical difficulty (easy, moderate, difficult). |
Countries
South Korea
Contacts
Primary ContactHyun Joo Ahn, MD PhD
Backup ContactHeejoon Jeong, MD
Outcome results
None listed