Hyperbaric Oxygen Therapy in Sickle Cell Pain

NCT03412045 | Completed FDA Device

• 1 other identifier: 0003-17-FB
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Sickle cell anemia is a genetic blood disorder where red blood cells are abnormally shaped, crescent- or sickle-shaped, instead of the normal, round shape. This misshapen cell is rigid and sticky, causing them to clump together and block small blood vessels. This blockage can lead to pain, infections, and organ damage, and the shortened lifespan of sickle cells causes anemia. The purpose of this study is to explore if hyperbaric oxygen (HBO) therapy would decrease pain and hospital length of stay associated with acute sickle cell pain crisis. Adults presenting with an uncomplicated acute pain crisis (i.e., acute chest syndrome, acute myocardial infarction/stroke) would be eligible. The intervention would be 1-3 hyperbaric oxygen sessions depending on response to therapy. Each treatment session will be approximately two hours in length. Evaluation would be through participants' self--assessment via the visual analog scale for pain level before and after treatments as well as tracking length of stay in the hospital.

Conditions

Vaso-occlusive Crisis; Sickle Cell Anemia Crisis

Outcome Measures

Primary Outcomes (1)

• Pain Assessment per Treatment

  Change in pain rating will be determined within one hour before and after each hyperbaric oxygen (HBO) treatment. The pain scale is 0-100, 0 being no pain and 100 being maximal pain imaginable for that participant. Pain assessments before and after each HBO treatment will be compiled and compared to determine treatment effectiveness.

  one hour before and after each hyperbaric treatment

Secondary Outcomes (2)

• Hospital Length of Stay

  up to 1 month

• Pain Assessment for All Treatments

  up to 1 month (expected average of 3 days)

Study Arms (1)

treatment

EXPERIMENTAL

This preliminary study will be a convenience sample of patients admitted to hospital for vaso-occlusive sickle cell crisis to be treated with hyperbaric oxygen (HBO), the intervention, in an effort to ameliorate pain and shorten the length of hospital stay.

Device: hyperbaric oxygen therapy

Interventions

hyperbaric oxygen therapy DEVICE

Participants in vaso-occlusive crisis from sickle cell anemia will receive 1-3 hyperbaric oxygen (HBO) sessions depending on response to the therapy. Each session will be approximately 2 hours in length at 2.5 ATM. Minimum time between HBO sessions of 4 hours.

treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Present with an uncomplicated sickle cell crisis at admission friom the emergency department

You may not qualify if:

• \< 19 years old
• pregnant female
• complicated sickle cell crisis present (i.e., concomitant MI, stroke, acute chest syndrome at time of presentation)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Vaso-Occlusive Crises

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Jeff S Cooper, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a convenience sample of patients admitted to hospital for vaso-occlusive sickle cell crisis to be treated with hyperbaric oxygen (HBO), the intervention, in an effort to ameliorate pain and shorten the length of hospital stay.

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: January 26, 2018
• Study Start: September 1, 2022
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)