Evaluation of Laryngeal Morbidity After Orotracheal Intubation by Vocal Analysis and Laryngostroboscopy

NCT03501095 | Completed

• 1 other identifier: AOCarita
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation Complication; Vocal Cord Dysfunction; Vocal Tone Disorder; Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

• Incidence, expressed as the number of new cases per year, of laryngeal complications arising after endotracheal intubation. This complications will be related to:

  1. the variation of voice parameters, during acoustic analysis, above 95% percentile, compared to healthy volunteers, of patients who undergo orotracheal intubation. 2. 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 Outcomes (4)

• Correlation between weight and modified Mallampati

  The data will be assessed during pre-surgery visit

• Correlation between endotracheal tube size and presence of laryngeal damage

  The data will be assessed 24 hours after surgery

• Correlation between use or not of mandrel and the modifications of Jitter %

  The data will be assessed 24 hours after surgery

• Correlation between use or not of mandrel and the modifications of Shimmer %

  The data will be assessed 24 hours after surgery

Study Arms (1)

patients

patients who must undergo general and/or urology surgery of an elective type

Diagnostic Test: Vocal analysis and Laryngostroboscopy

Interventions

Vocal analysis and Laryngostroboscopy DIAGNOSTIC_TEST

Vocal analysis study the acoustic emission of the pneumo-phono-articulatory system, i.e. the vocal signal. Currently, digital technology instruments enable the processing and analysis of the verbal signal quickly and reliably, also offering graphical products and numerical data. Among the various existing software products for the study of the vocal signal, PRAAT is available. In practice, the vocal parameters are acquired in a non-invasive way with a microphone. Laryngostroboscopy is one of the most widely used techniques for laryngeal clinical evaluation. This is a non-invasive endoscopic practice performed by means of a flexible fibroscope, which, through a pulsed light source, allows visualization of the chordal movement.

Also known as: Vocal analysis, Laryngostroboscopy

patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will study patients undergoing general anesthesia for urological or general surgery at the University Hospital (AOU) Maggiore della Carità di Novara in the time span between 1st April 2018 to 31st March 2019.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

AOU Maggiore della Carità

Novara, 28100, Italy

Location

Related Publications (7)

• 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.

  PMID: 25991942 BACKGROUND

• 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.

  PMID: 22431870 BACKGROUND

• 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.

  PMID: 12883393 BACKGROUND

• 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.

  PMID: 2232768 BACKGROUND

• Peppard SB, Dickens JH. Laryngeal injury following short-term intubation. Ann Otol Rhinol Laryngol. 1983 Jul-Aug;92(4 Pt 1):327-30. doi: 10.1177/000348948309200402.

  PMID: 6881831 BACKGROUND

• 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.

  PMID: 2319880 BACKGROUND

• 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.

  PMID: 16905292 BACKGROUND

MeSH Terms

Conditions

Vocal Cord Dysfunction

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical physician

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 18, 2018
• Study Start: April 17, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)