‘Does maintaining endotracheal tube cuff pressures at 20 mm Hg prevent dysphagia and hoarseness after anterior cervical spine surgery?’A randomised controlled trial.
Recruiting
- Conditions
- Dysphagia, hoarseness, anterior cervical spine surgery, endotracheal tube cuff pressures, sore throat
- Registration Number
- NL-OMON25072
- Lead Sponsor
- Medisch Centrum Haaglanden
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 164
Inclusion Criteria
1. Patients requiring primary anterior cervical spine surgery with the use of a retractor;
2. Male and non-pregnant female patients between 18-90 years of age;
Exclusion Criteria
1. Pre-operative dysphagia, sore throat or hoarseness;
2. Pre-operative recurrent laryngeal nerve palsy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative dysphagia. This will be scored with the Bazaz dysphagia scale twenty-four hours and 2 months after the operation.
- Secondary Outcome Measures
Name Time Method Postoperative sore throat, postoperative hoarseness and length of stay.<br /><br>Sore throat and hoarseness will be scored twenty-four hours and 2 months after the operation. Hoarseness will be scored using a clinician-based voice assessment protocol; Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) and by using a numeric rating scale (NRS). A sore throat will be recorded using a NRS.