Comparison of Arterial and Capillary Blood Gas Analyses in Patients With Respiratory Distress Due to COPD or APE

NCT07835945 | Recruiting

• 1 other identifier: 25-PP-13
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The assessment of gas exchange is crucial for the management of patients suffering from respiratory distress due to an exacerbation of chronic obstructive pulmonary disease (COPD) or cardiogenic acute pulmonary edema (APE). These measurements are used by physicians to determine the need for noninvasive ventilation (NIV) as well as to evaluate its effectiveness and to decide whether to continue the treatment. Arterial blood gas analysis is currently the gold standard for the measurement of these gas exchanges, though invasive, painful and risky (failure risks and possible local complications). Capillary blood gas analysis, which consists in collecting a blood drop from the ear or the finger by capillarity after punction, could represent a less invasive alternative. However, data comparing the performances of arterial and capillary blood gas analysis in the context of respiratory distress requiring a NIV remain limited. This study is based on the hypothesis that capillary blood gas analysis can perform as well as arterial blood gas analysis. It is aimed at comparing values obtained from arterial and capillary blood gas analyses from patients with respiratory distress and requiring a NIV due to an exacerbation of COPD or cardiogenic APE.

Conditions

Pulmonary Disease (COPD), Chronic Obstructive

Keywords

capillary blood gas analyses; arterial blood gas analyses; respiratory distress; COPD; APE

Outcome Measures

Primary Outcomes (1)

• Agreement between carbon dioxide pressure (PCO2) values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.

  Agreement between arterial and capillary pCO₂ measurements, assessed using Bland-Altman analysis with mean bias and the 95% limits of agreement

  Baseline (once the patient arrives at the emergency care unit and is included in the study)

Secondary Outcomes (15)

• Agreement between pH values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE

  Baseline (once the patient arrives at the emergency care unit and is included in the study)

• Agreement between bicarbonate concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.

  Baseline (once the patient arrives at the emergency care unit and is included in the study)

• Agreement between base concentration values obtained from capillary and arterial blood gas analyses in patients requiring a non-invasive ventilation due to an exacerbation of COPD or a cardiogenic APE.

  Baseline (once the patient arrives at the emergency care unit and is included in the study)

• Agreement between PCO2 values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.

  One hour after initiation of non-invasive ventilation.

• Agreement between pH values obtained from capillary and arterial blood gas analyses in patients with an exacerbation of COPD or a cardiogenic APE one hour after initiation of non-invasive ventilation.

  One hour after initiation of non-invasive ventilation.

Study Arms (1)

Respiratory distress arm requiring a noninvasive ventilation

EXPERIMENTAL

Diagnostic Test: Capillary blood gas analysis

Interventions

Capillary blood gas analysis DIAGNOSTIC_TEST

The intervention consists in carrying out arterial, veinous and capillary blood gas analyses before submitting the patient to noninvasive ventilation (5 minutes will separate each sampling). Data from these samplings will be recorded. 1 hour after the implementation of the noninvasive ventilation, patients will once again undergo arterial, veinous and capillary samplings for blood gas analyses. Respiratory parameters will be recorded as well at the onset of the noninvasive ventilation and one hour after its start.

Respiratory distress arm requiring a noninvasive ventilation

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years old
• Patients admitted in the emergency care unit with an exacerbation of COPD or a cardiogenic APE requiring a non-invasive ventilation (i.e. for COPD patients pH\< 7.35, for APE patients: PCO2 \> 45 mmHg)
• Patients affiliated to a social security system

You may not qualify if:

• Patients for which a non-invasive ventilation was initiated upon pre-hospital care
• Contraindication for non-invasive ventilation
• Patients for which non-invasive ventilation is not indicated
• Patients for which capillary or arterial blood gas analyses are impossible
• Adults subject to legal guardianship (guardianship, conservatorship)
• Pregnant women
• Patients with a congenital heart disease

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Nathalie Ducot, MD-PhD

CONTACT

+33 (0)4 92 03 32 42; ducot.n@chu-nice.fr

Charlotte Monge

CONTACT

+33 (0)7 87 51 25 93; monge.c@chu-nice.fr

Study Design

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

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): March 24, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-10

Locations

FR (1)