NCT03342209

Brief Summary

determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

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

March 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
Last Updated

April 10, 2018

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

October 28, 2017

Last Update Submit

April 8, 2018

Conditions

Keywords

carbon monoxide toxicityhigh flow nasal cannulaemergency department

Outcome Measures

Primary Outcomes (1)

  • Half life of COHb

    Half life of COHb levels (%) under the high flow nasal oxygen therapy. Elimination rate of COHb will be determined in every 10 minutes according to venous blood gas COHb level.

    between 20 and 120 minutes

Secondary Outcomes (4)

  • Adverse Events

    between 0 and 120 minutes

  • Device Comfort

    Between 0 and 120 minutes

  • Flow Rate Tolerability

    Between 0 and 120 minutes

  • Flow Temperature Tolerability

    Between 0 and 120 minutes.

Study Arms (1)

HFNC therapy

EXPERIMENTAL

Fisher\&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy will be implemented to CO-poisoned patients. Oxygen flow rate will be started 60 L/min and be decreased as the patient has requested.

Device: Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy

Interventions

A high flow nasal cannula will be implemented to the CO-poisoned patients. In the meantime, intravenous access and cardiac monitorization will have been establishing. When the high flow nasal cannula becomes ready, the first venous blood sample will be taken and the treatment will be started without any delay. The gas flow rate will be started at the rate of 30 liters per minute and will be increased to the max flow rate which patient can tolerate and FiO2 of 1.0. If the first COHb level is lesser than 10%, the patient will be excluded and will receive standard emergency care. The blood sample will be drawn from existing IV access every 10 minutes until the COHb levels become %50 or lesser of the initial level. Once the COHb level becomes 50% of initial measurement, following blood samples will be taken in every 30 minutes.

HFNC therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who are admitted to the emergency department with CO poisoning with a CoHB level of \>10%.
  • The patients who accept to participate in the study.

You may not qualify if:

  • The patients who are \<18 years old.
  • The patients who need mechanical ventilation
  • The patients who are implemented oxygen more than 30 minutes before the ED admission
  • The patients who will be transferred to the hyperbaric oxygen center before the CoHB levels are decreased to the half.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty

Kocaeli, Izmit, 41300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carbon Monoxide PoisoningEmergencies

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Yaka, Assoc. Prof.

    Kocaeli University

    STUDY CHAIR
  • İbrahim U Özturan

    Kocaeli University

    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
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator, MD

Study Record Dates

First Submitted

October 28, 2017

First Posted

November 14, 2017

Study Start

March 1, 2017

Primary Completion

February 6, 2018

Study Completion

February 6, 2018

Last Updated

April 10, 2018

Record last verified: 2017-11

Locations