NCT07042971Not yet recruiting
Peri-operative BiPAP to Prevent Tracheostomy in High-Risk Bilateral Vocal-Cord Paralysis (BVCP)
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
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 21 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Fujian Medical University
- Diseases
- Thyroid cancer
- NCT number
- NCT07042971
What you commit to
- Study type: Interventional
- Planned participants: 204
- From 1 Jul 2025 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery or need for immediate tracheostomy.
Other illness
- Craniofacial anomaly or skin condition precluding mask seal.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.