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

NCT07042971 | Not Yet Recruiting FDA Device

• 1 other identifier: BVCP-BiPAP
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vocal Cord Paralysis, Bilateral; Airway Obstruction, Postoperative; Thyroid Neoplasms; Sleep Apnea, Obstructive

Keywords

BiPAP; Non-invasive Ventilation; Continuous Positive Airway Pressure; Peri-operative Airway Management; Tracheostomy Avoidance; Thyroidectomy; Neck Surgery; Glottic Stenosis; Pre-operative Sleep Training; Voice Handicap Index

Outcome Measures

Primary Outcomes (1)

• Composite "Airway Failure" (Tracheostomy OR Re-intubation)

  Post-operative Day 0 through Day 7

  The first occurrence of (a) surgical tracheostomy or (b) endotracheal re-intubation for respiratory distress within 7 days after extubation. Event status adjudicated by an independent investigator using pre-defined criteria.

Secondary Outcomes (5)

• Total BiPAP Usage Hours

  Post-op Day 0 to Day 2 (48 hours)

• Hypoxemic Episodes (SpO₂ < 90 % ≥ 3 min)

  Post-op Day 0 to Day 2

• ICU Length of Stay

  Surgery end → ICU discharge (up to 7 days)

• Voice Handicap Index-10 (VHI-10)

  6 months (±14 days) post-op

• Normalized Glottic Area (NGA %)

  Baseline pre-op and 6 months post-op

Study Arms (4)

Training + Post-op BiPAP

EXPERIMENTAL

Participants receive 7-day Pre-operative BiPAP Training and Post-extubation BiPAP Support for ≥ 48 h after surgery.

Device: Post-extubation BiPAP Support; Other: Standard Peri-operative Care

Training Only

EXPERIMENTAL

Participants receive 7-day Pre-operative BiPAP Training. No routine BiPAP after extubation; peri-operative care otherwise standard.

Other: Standard Peri-operative Care

Post-op BiPAP Only

EXPERIMENTAL

No pre-op training. BiPAP started immediately after extubation and continued ≥ 48 h.

Device: Pre-operative BiPAP Training; Device: Post-extubation BiPAP Support

Standard Care

ACTIVE COMPARATOR

No planned BiPAP. Airway managed with institutional standard care only.

Device: Pre-operative BiPAP Training; Other: Standard Peri-operative Care

Interventions

Pre-operative BiPAP Training DEVICE

Seven consecutive nights (≥ 4 h/night) of BiPAP use at home or on ward, pressure ladder EPAP 6→8 cmH₂O / IPAP 12→16 cmH₂O, recorded on SD card; devices: ResMed AirCurve 10 ST or Philips A40.

Post-op BiPAP Only; Standard Care

Post-extubation BiPAP Support DEVICE

Same BiPAP device started immediately after tracheal extubation; EPAP 8 cmH₂O / IPAP 14 cmH₂O (or patient's final training setting) maintained ≥ 48 h, then weaned when SpO₂ ≥ 94 % off-BiPAP for 24 h.

Post-op BiPAP Only; Training + Post-op BiPAP

Standard Peri-operative Care OTHER

Routine oxygen, nebulized steroids, airway monitoring; rescue re-intubation or tracheostomy per institutional protocol; no planned BiPAP unless crossover criteria met.

Standard Care; Training + Post-op BiPAP; Training Only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, FJ, 350001, China

Location

MeSH Terms

Conditions

Vocal Cord Paralysis; Airway Obstruction; Thyroid Neoplasms; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Bo WANG, MD

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo WANG, MD

CONTACT

+8613959123550; wangbo@fjmu.edu.cn

WANG

CONTACT

13959123550; wangbo@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label; blinding not feasible because BiPAP mask/pressures are apparent. Primary endpoint (tracheostomy or re-intubation) is objective.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director & Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Model Details: Two-by-two factorial randomized controlled trial testing the independent and combined effects of (A) 7-day pre-operative BiPAP training and (B) immediate post-extubation BiPAP support.

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

CN (1)