Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning

NCT04656912 | Completed

• 1 other identifier: CO-HBO
• Study Type: observational
• Target: 706
• Locations: 1 country
• Sites: 1

Brief Summary

Hyperbaric oxygen therapy (HBO2) is recommended for symptomatic patients within 24 h of carbon monoxide (CO) poisoning. However, previous major studies found significantly better outcomes with HBO2 in patients treated within 6 h. Currently, there is no consensus on a CO poisoning-to-HBO2 interval that would not be beneficial. Therefore, the investigators aimed to evaluate the difference in therapeutic effect depending on the poisoning-to-HBO2 interval after CO exposure in patients with acute CO poisoning who received HBO2 within 24 h. The investigators compared the neurocognitive outcomes of patients according to HBO2 time intervals based on the outcomes of patients treated within 6 h (control group) with propensity score matching using the CO poisoning registry of our hospital.

Conditions

Hyperbaric Oxygenation; Carbon Monoxide Poisoning; Time

Outcome Measures

Primary Outcomes (2)

• Frequency of poor global deterioration scale (GDS) at 1 month after CO exposure in the overall matched cohort

  Frequency of poor GDS (4-7 scores) outcome at 1 month after CO exposure between early group and late group \*GDS (the minimum and maximum: 1-7, higher scores mean a worse outcome) Poor GDS outcome means from 4 to 7 in GDS score.

  At 1 month after CO exposure

• Frequency of poor GDS at 6 months after CO exposure in the overall matched cohort

  Frequency of poor GDS outcome at 6 months after CO exposure between early group and late group

  At 6 months after CO exposure

Secondary Outcomes (12)

• Frequency of poor GDS at 1 month after CO exposure between early group and case 1 group in the matched cohort

  At 1 month after CO exposure

• Frequency of poor GDS at 1 month after CO exposure between early group and case 2 group in the matched cohort

  At 1 month after CO exposure

• Frequency of poor GDS at 1 month after CO exposure between case 1 group and case 2 group in the matched cohort

  At 1 month after CO exposure

• Frequency of poor GDS at 6 months after CO exposure between early group and case 1 group in the matched cohort

  At 6 months after CO exposure

• Frequency of poor GDS at 6 months after CO exposure between early group and case 2 group in the matched cohort

  At 6 months after CO exposure

Study Arms (1)

Acute CO poisoning

A diagnosis of CO poisoning was made according to medical history and carboxyhemoglobin \>5% (\>10% in smokers).

Procedure: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapy PROCEDURE

Patients with any symptoms and signs were treated with HBO2. During the first HBO2, initial compression was performed to 2.8 atmospheres absolute (ATA) for 45 min, followed by 2.0 ATA for 60 min. If an additional HBO2 was possible within 24 h, then 2.0 ATA was administered for 90 min. Moreover, if necessary, patients were treated with HBO2, even after 24 h, until all symptoms resolved.

Acute CO poisoning

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CO poisoned patients

You may qualify if:

• CO poisoned patients

You may not qualify if:

• Not treated with HBO2
• \< 16 years old
• Non-acute CO poisoning
• Received HBO2 more than 24 h after poisoning
• A history of previous stroke or neurocognitive diseases
• Did not undergo follow-up until 6 months
• Received specific treatment other than HBO2, such as therapeutic hypothermia
• A history of previous CO exposure
• A serious illness that can affect the patient's prognosis such as advanced cancer
• A cardiac arrest before ED arrival
• No recorded data on important variables, such as time from CO exposure to the start of first HBO2

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Related Publications (1)

• Lee Y, Cha YS, Kim SH, Kim H. Effect of Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning. Crit Care Med. 2021 Oct 1;49(10):e910-e919. doi: 10.1097/CCM.0000000000005112.

  PMID: 34074856 DERIVED

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: September 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

KR (1)