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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Hyperbaric Oxygen Therapy; Middle Ear Barotrauma

Treatments: Procedure: Self-acupressure therapy; Procedure: Combined Valsalva and Toynbee maneuvers

Study type: Interventional

Funder types: Other

Identifiers

NCT04311437

CMRPG8K0461

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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152 participants in 2 patient groups, including a placebo group

Self-acupressure group

Experimental group

Description:

The subjects in experimental group will undergo additional self-acupressure therapy in addition to Valsalva and Toynbee maneuvers before the first HBOT. The acupoints used are TE17 (Yifeng, 翳風), TE21 (Ermen, 耳門), SI19 (Tinggong, 聽宮), GB2 (Tinghui, 聽會).

Treatment:

Procedure: Combined Valsalva and Toynbee maneuvers

Procedure: Self-acupressure therapy

Control group

Placebo Comparator group

Description:

The subjects in control group will receive Valsalva and Toynbee maneuvers alone.

Treatment:

Procedure: Combined Valsalva and Toynbee maneuvers