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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-25

Study Completion Date

2026-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Swallowing and Voice Outcomes After Thyroidectomy

NCT03436186

Functional Voice and Swallowing Outcomes

COMPLETED

Predisection Risk Factors for Vocal Cord Palsy After Total Thyroid Surgery

NCT04986592

Recurrent Laryngeal Nerve Palsy Risk Factors of Vocal Cord Palsy Neuromonitoring in Thyroid Surgery

COMPLETED

Non-neural Vocal Changes After Thyroidectomy

NCT02136459

Thyroidectomy

COMPLETED NA

Dysfunction Following Thyroid Surgery

NCT04087447

Thyroidectomy

UNKNOWN

The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery

NCT02996526

Vocal Cord Paresis Acquired Vocal Cord Palsy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

study protocol has been published and is attached below

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing thyroid surgery

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).

No interventions assigned to this group

Patients undergoing abdominal surgery

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.

No interventions assigned to this group

Patients undergoing other head and neck surgery besides thyroid

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).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes