Incidence of Postoperative Vocal Cord Palsy Between Double-lumen Endobronchial Tube and Bronchial Blocker for Robot-assisted Esophagectomy: a Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Samsung Medical Center
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Postoperative vocal cord palsy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
double-lumen endobronchial tube group
Intervention: double-lumen endobronchial tube (Device)
bronchial blocker group
Intervention: bronchial blocker (Device)
Outcomes
Primary Outcomes
Postoperative vocal cord palsy
Time Frame: 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 Outcomes
- Number of resected recurrent laryngeal nerve lymph nodes(At the end of surgery)
- Surgical difficulty reported by surgeon(At the end of surgery)
- Quality of one lung ventilation(during one lung ventilation)
Investigators
Hyun Joo Ahn
Professor, Anesthesiologist
Samsung Medical Center