Objective and Perceptual Characteristics of the Voice After Endotracheal Intubation in Head and Neck Surgery (VOICE)

Clinical Hospital Centre Zagreb

Status: Invitation-only

Conditions: Endotracheal Intubation During Surgery; Head and Neck Surgery; Voice Disorder Due to Iatrogenic Factor; Thyroid Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT07131800

Klasa8.1-23/209-3 Broj02/013AG;

Details and patient eligibility

About

Introduction: Possible consequences of endotracheal intubation are post-intubation voice changes.

Hypothesis: Endotracheal intubation during head and neck surgery is associated with objective and perceptual voice disorders.

Research objective: To investigate the short-term and long-term effects of endotracheal intubation on voice quality during head and neck surgery.

Material, subjects, methodology and research design: A prospective observational cohort study that will include patients undergoing surgery and endotracheal intubation lasting up to 3 hours. Adult patients divided into three groups will be included in the research: thyroid surgery, parotid gland surgery and abdominal surgery. Videostroboscopy, perceptual and objective acoustic voice analysis will be recorded before surgery, on the second postoperative day, two weeks and 1 month after surgery.

Expected scientific contribution of the proposed research: The scientific contribution would be an understanding of the risk factors and the connection of voice disorders after endotracheal intubation, as well as the ability to determine differences in this risk in patients undergoing different operations.

Full description

study protocol has been published and is attached below

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients scheduled for elective thyroid, head and neck surgery or abdominal surgery
• 18 and 70 years,
• normal preoperative voice status, and
• normal laryngeal status.

Exclusion criteria

• <18 years in the time of surgery
• history of previous head and neck operation or radiotherapy
• patients scheduled for head and neck operation that can alter acoustic characteristics of the voice (surgery of the nasal cavity, ear surgery, laryngeal surgery, jaw surgery).
• Patients with preoperatively diagnosed pathologic vocal cord findings (nodules, polyps, vocal cord paralysis),
• patients with postoperative injuries of the vocal cords, recurrent and superior laryngeal nerve,
• patients with laryngopharyngeal reflux,
• patients in whom postoperative evaluation of the voice cannot be performed due to uncooperativeness will also be excluded from the study.

Trial design

180 participants in 3 patient groups

Patients undergoing thyroid surgery

Description:

Patients undergoing scheduled thyroid surgery at the University Hospital Centre Zagreb under general endotracheal anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy).

Patients undergoing abdominal surgery

Description:

Patients undergoing scheduled abdominal surgery at Day surgery of University Hospital Centre Zagreb under general anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy). This will include laparoscopic abdominal procedures and other minor abdominal procedures done in Day surgery, and will be control group for head and neck surgical procedures.

Patients undergoing other head and neck surgery besides thyroid

Description:

Patients undergoing scheduled head and neck surgeries beside thyroid surgery at the University Hospital Centre Zagreb under general endotracheal anesthesia without preoperative voice disorder regardless of the cause (previous operations or irradiation on the neck, and damage to the recurrent laryngeal nerve (RLN) during thyroidectomy).