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

Hyperbaric Oxygen Therapy Clinical Trial

Official title:

Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy: a Nonrandomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04311437
• Other study ID #: CMRPG8K0461
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2021
• Source: Chang Gung Memorial Hospital
• Contact: Chun-Ting Liu, MD
• Phone: +886-7-7317123
• Email: juntin0214[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barotrauma
• Hyperbaric Oxygen Therapy
• Middle Ear Barotrauma

Intervention

Procedure:
• Self-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.
• Combined 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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).	1 month
Secondary	Overall ear discomfort levels	Estimated using a 10-cm visual analogue scale with anchor points of 0 (no discomfort) and 10 (maximum discomfort).	1 month