Breathing mask before and after neck surgery to prevent tracheostomy
Tests a breathing mask machine in adults at high risk of vocal-cord paralysis after surgery.
Plain-language title generated from the registry record
Registry title: Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)
Key facts
- Where
- Fuzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07042971, who can take part
Where in China
- Fujian Medical University Union HospitalFuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Medical University
- Trial code
- NCT07042971
- Record updated
- 29 June 2025
- Original description
Why: After thyroid or neck surgery, some patients can lose movement of both vocal cords (bilateral vocal-cord paralysis, BVCP). This can make breathing difficult and often leads to an emergency or preventive tracheostomy ("wind-pipe") surgery.Read full original descriptionShow less
A Multicenter, Randomized Controlled Trial of Pre-operative BiPAP Training and Post-extubation BiPAP Support to Reduce Peri-operative Tracheostomy or Re-intubation in Patients at High Risk for Bilateral Vocal-Cord Paralysis
Why: After thyroid or neck surgery, some patients can lose movement of both vocal cords (bilateral vocal-cord paralysis, BVCP). This can make breathing difficult and often leads to an emergency or preventive tracheostomy ("wind-pipe") surgery.
What: This study will test two simple ways to avoid a tracheostomy:
Pre-operative BiPAP sleep training - patients practice sleeping with a non-invasive BiPAP breathing machine for seven nights before surgery so they become comfortable with the mask and pressures.
Immediate post-extubation BiPAP support - the same BiPAP machine is started as soon as the breathing tube is removed in the operating room or recovery area.
How: Adults (18-80 years) who already have, or are at high risk of getting, BVCP will be randomly assigned to one of four groups in a 2 × 2 design:
• Group 1: training + post-op BiPAP • Group 2: training only • Group 3: post-op BiPAP only • Group 4: standard care (no planned BiPAP).
Main goal: To find out whether either or both BiPAP strategies reduce the need for tracheostomy or re-intubation during the first 7 days after surgery.
What participants do: Eligible patients will undergo routine surgery plus the assigned BiPAP plan. Breathing events, comfort, hospital stay, and voice quality will be recorded up to 6 months.
Potential benefit/risk: BiPAP is non-invasive and already FDA-cleared for home and hospital use, but some people may feel mask discomfort or air leaks. Trained staff will adjust settings and stop BiPAP if serious problems occur.
Inclusion: 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: Emergency surgery or need for immediate tracheostomy; Craniofacial anomaly or skin condition precluding mask seal; Existing tracheostomy or home ventilator dependence; Inability to protect airway (e.g., Glasgow Coma Scale < 13); Pregnancy or breastfeeding; Participation in another interventional trial that could interfere with study endpoints.