Hyperbaric Oxygen Therapy, Middle Ear Barotrauma
Conditions
Keywords
Hyperbaric oxygen therapy, Middle ear barotrauma, Acupressure
Brief summary
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.
Interventions
PROCEDURESelf-acupressure therapy
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.
PROCEDURECombined Valsalva and Toynbee maneuvers
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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a prospective nonrandomized controlled study. The participants will be assigned to two groups in a 1:1 ratio. The participants in the control group will receive conventional Valsalva and Toynbee maneuvers, while those in the experimental group will be given additional self-acupressure therapy.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Teed Classification | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of MEB | 1 month | 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). |
| Overall ear discomfort levels | 1 month | Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort). |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORChun-Ting Liu, MD
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
Outcome results
None listed