Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)

Launched by FUJIAN MEDICAL UNIVERSITY · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether using a breathing machine called BiPAP can help prevent the need for a tracheostomy (a surgery to create an opening in the windpipe) in people who are at high risk of losing movement in both vocal cords after thyroid or neck surgery. When both vocal cords don’t move properly, it can make breathing very difficult, sometimes requiring emergency surgery. The study will test two approaches: practicing with the BiPAP machine for a week before surgery to get used to it, and using the BiPAP machine right after surgery as soon as the breathing tube is removed.

Adults between 18 and 80 years old who are scheduled for thyroid or neck surgery and have a high risk of vocal cord paralysis may be eligible. This includes people whose vocal cords are already partly fixed or who have other risk factors like severe sleep apnea, large tumors near the nerves, or previous neck surgeries. Participants will be randomly placed into one of four groups—some will get both pre-surgery training and post-surgery BiPAP, some will get only one of these, and some will receive usual care without BiPAP. Throughout the study, doctors will monitor breathing, comfort, hospital stay, and voice quality for up to six months. BiPAP is a safe, non-invasive machine already used in hospitals and at home, though some may find the mask uncomfortable. Trained staff will help manage the machine and stop its use if any problems arise. This study aims to find out if these simple breathing support methods can reduce the need for more invasive procedures after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 - 80 years.
• • Scheduled for thyroidectomy or other neck surgery under general anesthesia.
• * High risk of bilateral vocal-cord paralysis (BVCP) defined by at least ONE of:
• • Pre-operative flexible laryngoscopy showing fixed vocal cords at midline or paramedian position, or glottic gap ≤ 3 mm; OR
• * Presence of ≥ 2 high-risk factors:
• • Planned bilateral central plus lateral neck dissection
• • Re-operative bilateral neck surgery or dense scarring
• • Tumor involving both recurrent laryngeal nerves or crico-arytenoid joints
• • Severe obstructive sleep apnea (AHI ≥ 30 events/hour)
• • Body-mass index (BMI) ≥ 30 kg/m²
• • Able to tolerate and give informed consent for BiPAP mask use.
• Exclusion Criteria:
• • Emergency surgery or need for immediate tracheostomy.
• • Existing tracheostomy or home ventilator dependence.
• • Inability to protect airway (e.g., Glasgow Coma Scale \< 13).
• • Craniofacial anomaly or skin condition precluding mask seal.
• • Pregnancy or breastfeeding.
• • Participation in another interventional trial that could interfere with study endpoints.