Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

October 31, 2024

Study Completion Date

December 1, 2024

Conditions
Ear BarotraumaMiddle Ear DiseaseEar DiseasesPressure InjuryEustachian Tube DysfunctionMiddle Ear; InjuryMiddle Ear Barotrauma
Interventions
PROCEDURE

Compression Profile/Schedule: 15 minute Non-Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)

Patients will be compressed according to the 15 minute non-linear compression schedule on a rotating daily basis. A total of 2 randomized hyperbaric treatment compression profiles (accepted standards of care) will be alternated over the patients course of treatment on a daily basis daily to the prescribed treatment depth. There are multiple patients exposed during the compression profile randomized for that day. The patients are exposed over the course of 4-12 weeks using one of the two compression protocols to be studied on alternating days.

PROCEDURE

Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)

Patients will be compressed according to the 15 minute linear compression schedule on a rotating daily basis with compression. A total of 2 randomized hyperbaric treatment compression profiles (accepted standards of care) will be alternated over the patients course of treatment on a daily basis daily to the prescribed treatment depth. There are multiple patients exposed during the compression profile randomized for that day. The patients are exposed over the course of 4-12 weeks using one of the two compression protocols to be studied on alternating days.

Trial Locations (1)

10591

RECRUITING

Phelps Hospital Northwell Health, Sleepy Hollow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER

NCT04804098 - Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study. | Biotech Hunter | Biotech Hunter