|- candidate number||8520|
|- NTR Number||NTR2549|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-okt-2010|
|- Secondary IDs||NL33665.068.10 / 10-2-075 CCMO / METC Maastricht|
|- Public Title||Vocal cord pathology after short term intubation.|
|- Scientific Title||Vocal cord pathology after short term intubation.|
|- hypothesis||Long-term and crash intubations have adverse effects on the vocal folds. After short term endotracheal intubation (less than 3 hours) hoarseness complaints do exist, but its effect on the vocal folds is unknown. We aim to investigate the incidence and severity of vocal fold pathology after short term intubation. |
|- Healt Condition(s) or Problem(s) studied||Intubation, Vocal cord pathology|
|- Inclusion criteria||All adult (>18years) patients, male and female undergoing an elective procedure under general anaesthesia requiring endotracheal intubation or laryngeal mask ventilation. Short term is defined as lasting less than 3 hours.|
|- Exclusion criteria||1. Upper airway and neck operations, procedures after which the view on the larynx is hindered;|
2. Procedures taking more than 3 hours.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||18-okt-2010|
|- planned closingdate||30-jun-2011|
|- Target number of participants||200|
|- Interventions||1. Videolaryngostroboscopy;|
2. Acoustic analysis;
3. Voice Handicap Index (questionnaire).
|- Primary outcome||Vocal fold pathology documented by videolaryngostroboscopy, voice analysis and validated questionnaires.|
|- Secondary outcome||N/A|
|- Timepoints||1. Day 0: Data collection;|
2. Day 1: Data collection;
3. Day 15-42: Data collection.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD. J.W. Brunings|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. B. Kremer|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Maastricht University Medical Center (MUMC+)|
|- Brief summary||Rationale: |
Long-term and crash intubations have adverse effects on the vocal folds. After short term endotracheal intubation (less than 3 hours) hoarseness complaints do exist, but its effect on the vocal folds is unknown. We aim to investigate the incidence and severity of vocal fold pathology after short term intubation.
Primary Objective: Is there any vocal fold pathology after short term intubation?
1. Which vocal fold pathology occurs after short term intubation?
2. What is the effect of short term intubation on voice quality?
3. What are the subjective findings of the patients regarding their voice after short term intubation?
We propose to perform a structured, prospective observational study to document the existence of vocal fold pathology and to categorize vocal fold pathology after short term intubation and to ask patients about their voice quality after short term intubation.
Based on the findings of this study, future studies can be designed aimed at optimizing intubation techniques, devices and material.
Adult patients, planned for elective surgery under general anaesthesia requiring endotracheal or laryngeal mask intubation.
Short term intubation evaluated by videolaryngostroboscopy, voice analysis, validated questionnaires.
Main study parameters/endpoints:
Vocal fold pathology documented by videolaryngostroboscopy, voice analysis and validated questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participants will be asked to complete the Voice Handicap Index (VHI) pre- and post-operatively, this takes approximately 10 minutes.
A videolaryngostroboscopy is performed pre- and post-operatively. With a rigid 90 degree endoscope the vocal folds are monitored via the mouth while the participant is making an [i]-like sound. Seldom a retching feeling occurs during this test. Vomiting is very rare.
The participants will undergo an acoustic analysis of the voice whereby a microphone is attached to the head which does not provide any discomfort.
|- Main changes (audit trail)|
|- RECORD||1-okt-2010 - 26-nov-2010|