Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy

Chang Gung Memorial Hospital152 enrolled

Overview

Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB associated with HBOT. The aim of this protocol is to investigate the efficacy of self-acupressure therapy on MEB associated with HBOT.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

152

Conditions

Hyperbaric Oxygen Therapy Middle Ear Barotrauma

Interventions

Self-acupressure therapyPROCEDURE

The self-acupressure therapy is as follows: Patients are in sitting position, applied firm pressure (3-5 kg of pressure) with the fingertips in a circular motion at a speed of two circles per second for a duration of one min per acupoint. A 1-2-s rest is applied after each ten circles. The complete process lasts for about 5 min.

Combined Valsalva and Toynbee maneuversPROCEDURE

Valsalva maneuver: blowing against a closed mouth and nostrils, increasing the middle ear pressure. Toynbee maneuver: swallowing while the mouth and nostrils are closed, decreasing the middle ear pressure.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 20 years or order receiving the first HBOT * Alert consciousness Exclusion Criteria: * Pregnancy * Having any acute disorder of the ears or upper respiratory tract * Having evidence of neurologic dysfunction precluding them from making an informed decision * Having a tracheostomy or endotracheal intubation * Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.

Locations (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Modified Teed Classification

The Modified Teed Classification, with grades from 0 to 5: Grade 0 indicates symptoms with no ontological signs of trauma; Grade 1 indicates injection of the tympanic membrane; Grade 2 indicates Grade 1 plus injection plus mild hemorrhage within the tympanic membrane; Grade 3 indicates gross hemorrhage within the tympanic membrane; Grade 4 indicates free blood in the middle ear as evidenced by blueness and bulging; and Grade 5 indicates perforation of the tympanic membrane.

Time frame: 1 month

Secondary Outcomes

Symptoms of MEB

Record the symptoms of MEB including feeling pressure in the ears, ear pain, headache, dizziness, vertigo, tinnitus and hearing loss. Each symptom is estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).

Time frame: 1 month

Overall ear discomfort levels

Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).

Time frame: 1 month

Central Contacts

Chun-Ting Liu, MD

CONTACT

+886-7-7317123 juntin0214@gmail.com

Data from ClinicalTrials.gov

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