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

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

Interventions

DEVICE

Pre-operative BiPAP Training

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.

DEVICE

Post-extubation BiPAP Support

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.

OTHER

Standard Peri-operative Care

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

Sponsors & Collaborators

• Fujian Medical University

  lead OTHER

Principal Investigators

• Bo WANG, MD · Fujian Medical University Union Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2028-07-01

Completion

2029-12-31

FDA Device

Yes

Countries

• China

Study Locations