Intubation Complication Clinical Trial
Official title:
Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy: A Pilot Study
NCT number | NCT03501095 |
Other study ID # | AOCarita |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 17, 2018 |
Est. completion date | March 31, 2019 |
Verified date | January 2023 |
Source | Azienda Ospedaliero Universitaria Maggiore della Carita |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The delicate structures of the larynx can be compromised by innumerable causes, one of these is represented by endotracheal intubation. More frequently, these damages are represented by hematomas, edema and granulomas of the vocal cords. The pathophysiology of laryngeal damage can be explained by an ischemic attack of the chordal mucosa. Numerous risk factors can cause the onset of damage, some depending on the practice itself, such as size and type of endotracheal tube, cuff pressure, use of mandrels and / or inserting devices, use of oral or nasogastric tubes, use of neuromuscular inhibitors or sleep-inducing drugs and the duration of the intervention; others from patient-related factors, such as gender, weight, history of exposure of smoking habit, or a history of gastroesophageal reflux (GERD). The incidence of such symptoms varies from 0% to 18% among the general population, with an average of 6% with resolution of most of the symptoms within 72 hours unless substantial damage has occurred to the vocal cords or to the arytenoids. In general, the incidence of such laryngeal complications has been described by several studies, but there is no standardized protocol for measuring and evaluating their entity. The purpose of this study is to determine how the voice and the chordal clinical aspect vary after oro-tracheal intubation, evaluated through voice analysis and laryngostroboscopy.
Status | Completed |
Enrollment | 480 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - all patients between the age of 18 and 70 years old who have given informed consent and who must undergo general or urological surgery will be included. Exclusion Criteria: - age: below 18 or over 70 years old, - refusal of the patient to consent, - risk of the American Society Anesthesiologists (ASA) > III, - patients previously subjected to demolition surgery of head-neck and/or chemo-radiotherapy of the same structures, - patients with a history of hoarseness, vocal tract abnormalities and / or hearing impairment. |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Maggiore della Carità | Novara |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita |
Italy,
Beckford NS, Mayo R, Wilkinson A 3rd, Tierney M. Effects of short-term endotracheal intubation on vocal function. Laryngoscope. 1990 Apr;100(4):331-6. doi: 10.1288/00005537-199004000-00001. — View Citation
Hamdan AL, Sibai A, Rameh C, Kanazeh G. Short-term effects of endotracheal intubation on voice. J Voice. 2007 Nov;21(6):762-8. doi: 10.1016/j.jvoice.2006.06.003. Epub 2006 Aug 14. — View Citation
Horii Y, Fuller BF. Selected acoustic characteristics of voices before intubation and after extubation. J Speech Hear Res. 1990 Sep;33(3):505-10. doi: 10.1044/jshr.3303.505. — View Citation
Maktabi MA, Smith RB, Todd MM. Is routine endotracheal intubation as safe as we think or wish? Anesthesiology. 2003 Aug;99(2):247-8. doi: 10.1097/00000542-200308000-00002. No abstract available. — View Citation
Mendels EJ, Brunings JW, Hamaekers AE, Stokroos RJ, Kremer B, Baijens LW. Adverse laryngeal effects following short-term general anesthesia: a systematic review. Arch Otolaryngol Head Neck Surg. 2012 Mar;138(3):257-64. doi: 10.1001/archoto.2011.1427. — View Citation
Mota LA, de Cavalho GB, Brito VA. Laryngeal complications by orotracheal intubation: Literature review. Int Arch Otorhinolaryngol. 2012 Apr;16(2):236-45. doi: 10.7162/S1809-97772012000200014. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence, expressed as the number of new cases per year, of laryngeal complications arising after endotracheal intubation. This complications will be related to: | the variation of voice parameters, during acoustic analysis, above 95% percentile, compared to healthy volunteers, of patients who undergo orotracheal intubation.
the presence or absence of laryngeal damage at laryngostroboscopy. |
Presence of laryngeal damage 24-48 hours after surgery not visible at the pre-surgery visit. | |
Secondary | Correlation between weight and modified Mallampati | On the x axis will be plotted the weight measured in kilograms, on y axis will be plotted Mallampati scale. | The data will be assessed during pre-surgery visit | |
Secondary | Correlation between endotracheal tube size and presence of laryngeal damage | the size tube is measured in millimeters while laryngeal damage will be measured by Mendel's scale | The data will be assessed 24 hours after surgery | |
Secondary | Correlation between use or not of mandrel and the modifications of Jitter % | The Jitter % will be measured with software PRAAT | The data will be assessed 24 hours after surgery | |
Secondary | Correlation between use or not of mandrel and the modifications of Shimmer % | The Shimmer % will be measured with software PRAAT | The data will be assessed 24 hours after surgery |
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