NCT06198595

Brief Summary

Carbon monoxide (CO) poisoning is a condition that occurs as a result of inhaling carbon monoxide gas and can potentially lead to serious health issues. The treatment of CO poisoning requires urgent medical intervention. Methods used in the treatment of CO poisoning include normobaric oxygen (oxygen at normal pressure), high-flow oxygen, non-invasive continuous positive airway pressure (CPAP), and hyperbaric oxygen therapy. Studies on these methods are available in the literature.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

December 11, 2023

Last Update Submit

January 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Carboxyhemoglobin

    Blood carboxyhemoglobin saturation is typically expressed as a percentage. For example, the statement "blood carboxyhemoglobin saturation is 5%" indicates that 5% of hemoglobin has been converted to carboxyhemoglobin. This ratio affects the oxygen-carrying capacity of the blood and serves as an indicator of carbon monoxide poisoning. After treatment, a decrease in this ratio signifies the elimination of carbon monoxide from the body and the restoration of normal oxygen-carrying function.

    6 hours later

  • lactate

    Blood lactate levels are typically measured in millimoles per liter (mmol/L)

    6 hours later

Study Arms (3)

Normobaric oxygen therapy group

"Patients Receiving Oxygen from Hospital Circuits at Normal Atmospheric Pressure"

Noninvasive mechanical ventilation group

"Patients Receiving High PEEP Oxygenation Without Advanced Airway via Mechanical Ventilation"

EzPAP Positive Airway Pressure System

"Patients Receiving Positive Airway Pressure Support for Lung Expansion Without Advanced Airway via the EzPAP Device."

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who present to the emergency department with or are brought in due to CO intoxication will be included in the study.

You may qualify if:

  • Between the ages of 18 and 65,
  • Without any underlying health conditions,
  • Diagnosed with carbon monoxide poisoning,
  • Capable of providing consent either personally or through a legal representative.

You may not qualify if:

  • Under the age of 18,
  • Over the age of 65,
  • With underlying health conditions,
  • Without a diagnosis of carbon monoxide poisoning,
  • Patients who do not wish to share their data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, Çankaya, 06170, Turkey (Türkiye)

Location

Related Publications (6)

  • Akkan S, Uyanik O. Comparing high-flow nasal oxygen therapy and normobaric oxygen therapy on the treatment of carbon monoxide poisoning. Med Klin Intensivmed Notfmed. 2024 Apr;119(3):214-219. doi: 10.1007/s00063-023-01044-5. Epub 2023 Aug 2.

    PMID: 37530814BACKGROUND
  • Kim YM, Shin HJ, Choi DW, Kim JM, Lee SW, Jeong SH, Kim H. Comparison of high-flow nasal cannula oxygen therapy and conventional reserve-bag oxygen therapy in carbon monoxide intoxication: A pilot study. Am J Emerg Med. 2020 Aug;38(8):1621-1626. doi: 10.1016/j.ajem.2019.158451. Epub 2019 Nov 6.

    PMID: 31706658BACKGROUND
  • Ozturan IU, Yaka E, Suner S, Ozbek AE, Alyesil C, Dogan NO, Yilmaz S, Pekdemir M. Determination of carboxyhemoglobin half-life in patients with carbon monoxide toxicity treated with high flow nasal cannula oxygen therapy. Clin Toxicol (Phila). 2019 Jul;57(7):617-623. doi: 10.1080/15563650.2018.1540046. Epub 2019 Jan 28.

    PMID: 30689450BACKGROUND
  • Turgut K, Yavuz E. CPAP versus HFNC use in carbon monoxide poisoning. Am J Emerg Med. 2021 Aug;46:727. doi: 10.1016/j.ajem.2020.09.085. Epub 2020 Oct 2. No abstract available.

    PMID: 33036847BACKGROUND
  • Roth D, Mayer J, Schreiber W, Herkner H, Laggner AN. Acute carbon monoxide poisoning treatment by non-invasive CPAP-ventilation, and by reservoir face mask: Two simultaneous cases. Am J Emerg Med. 2018 Sep;36(9):1718.e5-1718.e6. doi: 10.1016/j.ajem.2018.05.066. Epub 2018 May 29.

    PMID: 29866417BACKGROUND
  • Caglar B, Serin S, Yilmaz G, Torun A, Parlak I. The Impact of Treatment with Continuous Positive Airway Pressure on Acute Carbon Monoxide Poisoning. Prehosp Disaster Med. 2019 Dec;34(6):588-591. doi: 10.1017/S1049023X19005028. Epub 2019 Oct 22.

    PMID: 31637993BACKGROUND

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • SAFA DÖNMEZ, MD

    ANKARA BİLKENT CİTY HOSPİTAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 10, 2024

Study Start

November 1, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations