|- candidate number||13131|
|- NTR Number||NTR3542|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jul-2012|
|- Secondary IDs||NL3582909811 CCMO|
|- Public Title||‘Does maintaining endotracheal tube cuff pressures at 20 mm Hg prevent dysphagia and hoarseness after anterior cervical spine surgery?’|
A randomised controlled trial.
|- Scientific Title||‘Does maintaining endotracheal tube cuff pressures at 20 mm Hg prevent dysphagia and hoarseness after anterior cervical spine surgery?’|
A randomised controlled trial.
|- hypothesis||Incidence of post-operative sore dysphagia, sore throat and hoarseness in patients getting anterior cervical spine surgery is not influenced by correction of tube cuff pressure to 20 mm Hg (normal value) after placement of a retractor in the operation wound.
|- Healt Condition(s) or Problem(s) studied||Dysphagia, Hoarseness, Sore throat, Anterior cervical spine surgery, Endotracheal tube cuff pressures|
|- 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;
3. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
|- Exclusion criteria||1. Pre-operative dysphagia, sore throat or hoarseness;|
2. Pre-operative recurrent laryngeal nerve palsy;
3. Dutch language not mastered;
4. Planned fiberoptic intubation or rapid sequence induction;
5. Peroperative use of N2O;
6. Mentally disabled patients.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||6-jan-2012|
|- planned closingdate||6-jul-2013|
|- Target number of participants||164|
|- Interventions||Study patients are randomized in two arms. In the control arm endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention arm endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg during the length of the operation.|
|- Primary outcome||Postoperative dysphagia. This will be scored with the Bazaz dysphagia scale twenty-four hours and 2 months after the operation.|
|- Secondary outcome||Postoperative sore throat, postoperative hoarseness and length of stay.|
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.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Bas Veld, in 't|
|- CONTACT for SCIENTIFIC QUERIES|| Bas Veld, in 't|
|- Sponsor/Initiator ||Medisch Centrum Haaglanden|
(Source(s) of Monetary or Material Support)
|Medisch Centrum Haaglanden|
|- Brief summary||In anterior cervical spine surgery a retractor is used. Previous studies showed an increase of endotracheal tube cuff pressures after placement of a retractor. It is known that a high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and a sore throat. However, until now no evidence supports maintaining the endotracheal tube cuff pressure during anterior cervical spine surgery to prevent this comorbidity.|
Our objective is to determine if adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery prevents postoperative dysphagia. Furthermore laryngo-tracheal complaints (hoarseness and sore throat) will be scored.
Study patients are randomized in two arms. In the control arm endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention arm endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg. Twenty-four hours and 2 months after the operation study patients are questioned about dysphagia, hoarseness and sore throat.
One hundred seventy-seven study patients aged 18-90 years scheduled for anterior cervical spine surgery on 1 or more levels with the use of a retractor will be randomized.
In the control arm no endotracheal tube cuff pressure intervention is performed after retractor application. In the intervention arm the endotracheal tube cuff pressure is maintained at 20 mm Hg after placement and after removal of the retractor. Main study parameters/ end points are postoperative dysphagia, sore throat and hoarseness.
|- Main changes (audit trail)|
|- RECORD||11-jul-2012 - 13-aug-2012|