Use of Hyperbaric Oxygen Therapy for the Treatment of Crush Injuries
NCT ID: NCT04049721
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-09-01
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care without HBO
Intravenous access and fluid resuscitation (standard of care treatment)
Standard of Care
20 patients will be included in the retrospective review arm. The retrospective chart review will be performed to determine the outcomes of patients with crush injuries treated at NYU Winthrop Hospital without HBO from 1/1/2012-12/31/2018.
HBO + Standard of Care
Ten daily treatment sessions of HBO at 2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks
HBO
2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks.
Standard of Care
20 patients will be included in the retrospective review arm. The retrospective chart review will be performed to determine the outcomes of patients with crush injuries treated at NYU Winthrop Hospital without HBO from 1/1/2012-12/31/2018.
Interventions
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HBO
2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks.
Standard of Care
20 patients will be included in the retrospective review arm. The retrospective chart review will be performed to determine the outcomes of patients with crush injuries treated at NYU Winthrop Hospital without HBO from 1/1/2012-12/31/2018.
Eligibility Criteria
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Inclusion Criteria
* No contraindication to hyperbaric oxygen therapy.
* Able and willing to sign informed consent.
Exclusion Criteria
* Crush injury isolated to the distal phalanx (Tuft fracture).
* Absolute contraindication to hyperbaric oxygen therapy (untreated pneumothorax). Relative contraindications (uncontrolled congestive heart failure, uncontrolled seizure disorder, pulmonary disease, claustrophobia) will be assessed by the treating physician.
* Unable or unwilling to sign informed consent.
18 Years
99 Years
ALL
No
Sponsors
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Winthrop University Hospital
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Patrizio Petrone, MD
Role: PRINCIPAL_INVESTIGATOR
New York Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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s19-01074
Identifier Type: -
Identifier Source: org_study_id
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