Using a brief swallowing test to detect vocal cord paralysis after major lung surgery
Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection
NA · University Hospital, Rouen · NCT05193240
This trial will test whether a quick swallowing test performed by a physiotherapist can find vocal cord paralysis in adults after major lung resection for lung cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen (other) |
| Locations | 1 site (Rouen) |
| Trial ID | NCT05193240 on ClinicalTrials.gov |
What this trial studies
Researchers will compare a physiotherapist‑administered preliminary bedside swallowing test performed after surgery with the standard postoperative nasofibroscopy to identify ipsilateral vocal cord paresis or paralysis. The study enrolls adults undergoing major left lung resection or right lung resection with upper lymph node dissection for lung cancer. Patients with preexisting swallowing disorders, neurological sequelae, or preoperative nasogastric feeding are excluded. The goal is to determine whether the simpler bedside test can reliably flag patients at risk of aspiration and other complications so that targeted ENT evaluation and management can follow.
Who should consider this trial
Good fit: Adults (≥18) scheduled for major left lung resection or right lung resection with upper lymph node dissection for lung cancer who can read, consent, and are not pregnant or breastfeeding are ideal candidates.
Not a fit: Patients with prior swallowing disorders, known neurological impairments, preoperative nasogastric feeding, or those unable to consent are unlikely to benefit from this screening approach.
Why it matters
Potential benefit: If successful, the bedside swallowing test could enable earlier detection of vocal cord paralysis after lung surgery and help prevent aspiration, feeding problems, and longer hospital stays.
How similar studies have performed: Bedside swallowing tests have shown mixed but often promising results in other surgical and neurological settings, while their specific use to predict vocal cord palsy after lung resection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥ 18 years old) * Patient who is scheduled for a major left lung resection surgery (segmentectomy, lobectomy, pneumonectomy) or a right lung resection with upper lymph node dissection in the context of lung cancer * Patient who capable to read and understand the patient information and consent. * Patient capable to read and sign the consent form * Patient with social insurance * Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy) * Negative urine pregnancy test Exclusion Criteria: * History of swallowing or eating disorders, * Neurological history with known sequelae or cognitive disorders * Preoperative nasogastric tube feeding * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship, * Pregnant or breastfeeding woman * Patient participating in another clinical trial with the same primary outcome
Where this trial is running
Rouen
- Rouen University Hospital — Rouen, France (RECRUITING)
Study contacts
- Principal investigator: Baptiste MICHAUX, physiotherapist — University Hospital, Rouen
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adults Patients Undergoing Major Lung Resection in the Context of Lung Cancer