HelpILO - RCT on EILO Treatment

Summary

Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high intensity exercise.

Conditions

• Exercise Induced Laryngeal Obstruction (EILO)

Interventions

PROCEDURE

A: Breathing advice with bio-feedback

Information and breathing advice with biofeedback will serve as an active comparator in this study, and time allowed for IBA and biofeedback in this study will be max 30 min. The teaching will be provided by the attending physician and the test leader. The session will follow a strict checklist. After the laryngoscope has been secured in correct position the patient will be shown his/her larynx on the screen, providing the patient with basic knowledge on laryngeal anatomy and function in a calm atmosphere before the CLE-test. After, the patients will be trained to make any symptoms abate, and a good breathing posture and how to optimally use their breathing muscles.

PROCEDURE

B: Breathing advice with bio-feedback, Inspiratory muscle training (IMT)

Breathing advise and IMT. The inspiratory muscle training (IMT) will build on the information the patients have obtained during the IBA and biofeedback session. The IMT will focus on training endurance and coordination of the PCA muscle, aiming to reduce fatigue of the abducting capacity of the larynx and to enhance coordination and create a sense of laryngeal control. When performing the IMT sessions, it is of utmost importance that a functional diaphragmatic breathing pattern has been established, and that this breathing pattern is maintained throughout all the IMT sessions. Once the patient has demonstrated that he/she is able to perform breathing according to these principles, the IMT session will follow a detailed protocol while wearing a flexible laryngoscope and settings and techniques are adjusted to ensure max open larynx. The patient will perform IMT training at home as instructed and have video meetings one and three weeks after initial training to observe progress.

PROCEDURE

C: Breathing advice with bio-feedback, Speech Therapy

The training period with the speech therapist takes three days, divided into 6 sessions. The training is continued at home, implementing the techniques during physical activity and at rest. The aim of the speech therapy is to help the patients to develop a strategy on how to control his/her larynx during exercise, and to be able to continue exercising without experiencing dramatic EILO incidents. They will be informed that the best approach is to start practicing while performing low to moderate intensity exercise, and then gradually increase the intensity as they become more confident. It will be emphasized that the new breathing technique they are about to adopt will need to be repeated until it becomes adapted as a part of their automated breathing pattern. Patients will be followed up with video meetings one and three weeks after initial training to observe progress.

PROCEDURE

D: Breathing advice with bio-feedback, IMT and Speech Therapy

All treatments as described above.

PROCEDURE

A: If CLE-test unchanged, additional IMT and Speech Therapy

All treatments as described above.

PROCEDURE

Surgery 1: Supraglottoplasty - full procedure under general anesthesia

Endoscopic supraglottoplasty with carbon dioxide laser and cold steel microlaryngeal instruments. The patient is intubated with an armored laser-tube which is positioned in the posterior midline to protect this area from laser injury. The laryngoscope is positioned into the vallecula and the surgery is visualized through an operation-microscope. CO2-laser beams of 2-4W focused with micro spot is utilized. Releasing incisions are made at the anterior border of both AEFs. The depth of the incisions are limited to the cranial border of the ventricular folds. The cuneiform tubercles including their surrounding mucosa are removed in a circular pattern before the two incisions are adjoined, thus creating a drop shaped excision. Care is taken to avoid scarring. It is recommended to protect the posterior commissure and the piriform sinus with wet tissue cloths. In case of perioperative edema of the laryngeal mucosa, corticosteroids are administrated to prevent laryngeal edema post-operatively.

PROCEDURE

Surgery 2: Supraglottoplasty - mini-invasive procedure under general anesthesia

Endoscopic supraglottoplasty with carbon dioxide laser. The patients are intubated with an armored laser-tube, which is positioned in the posterior midline to protect this area from laser injury. The laryngoscope (Benjamin/Lindholm) is positioned into the vallecula and the surgery is visualized through an operation-microscope. CO2-laser beams of 2-4W focused with micro spot are utilized. Four punctures will be made along the lateral borders of both aryepiglottic folds bilateral, thus creating a row of small punctures parallel to the rim of the aryepiglottic folds. The punctions should not be deeper than the incision in the "full procedure" (above); i.e. less than 5 millimeter, and care must be taken to avoid heat affecting the nervus recurrens posteriorly. Care is taken to avoid scarring and collateral thermal injury. It is recommended to protect the posterior commissure and the piriform sinus with wet tissue cloths. No antibiotic prophylaxis is administered.

Sponsors & Collaborators

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Hege H Clemm, MD, PhD · Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-12-31

Completion

2036-12-31

Countries

• Norway

Study Locations