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Treatment of Acute Hypercapnic Respiratory Failure With OptiflowTM or Optiflow+DuetTM Nasal Cannula in COPD-patients

NCT06257667 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-02-14

No results posted yet for this study

Summary

Hypothesis Treatment with HFNC and OptiflowTM+Duet can significantly reduce PaCO2 and normalize pH in patients with COPD exacerbation and acute hypercapnic failure, compared to HFNC with OptiflowTM.

Treatment with High flow and OptiflowTM+Duet in patients with COPD exacerbation and acute hypercapnic failure is well tolerated.

Aims To investigate the effect of HFNC in combination with either OptiflowTM or OptiflowTM+Duet nasal cannula on PaCO2 levels and pH in patients with COPD exacerbation and acute hypercapnic failure and compare the results of treatment with the two different nasal cannulas.

To describe adherence to treatment with high flow and either OptiflowTM or OptiflowTM+Duet nasal cannula.

Methods Study design The study will be carried out as a prospective, multicenter, randomized controlled trial.

* Patients COPD and acute hypercapnic who do not tolerate NIV-treatment will be treated with HFNC for respiratory support. Patients will be randomized to either OptiflowTM /OptiflowTM+Duet nasal cannulas ("Fisher \& Paykel Healthcare", Auckland, New Zealand)
* HFNC treatment with allocated nasal cannula, flow 40-60 (prescribed by the responsible clinician) will be initiated, titration of FiO2 till target SO2 is reached (as prescribed by the responsible clinician or by default 88-92%). Maximal flow and target saturation should be reached within 1.5 hours of initiation.
* Arterial puncture (registering pH, PaO2, PaCO2, HCO3, SaO2 and Base Excess) will be drawn at baseline and repeated after two hours (±30 minutes and after flow and FiO2 have been stable for 30 minutes) and at termination of the HFNC.
* Patients will remain in study till it is decided by the treating physician to terminate HFNC-treatment. Patients who are candidates for invasive ventilations will be excluded from the study if the arterial blood gasses further deteriorate after initiation of HFNC.

Conditions

  • Hypercapnic Respiratory Failure
  • COPD

Interventions

OTHER

Respiratory Support

Treatment with High Flow Nasal Cannula

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Viborg Regional Hospital

    collaborator OTHER

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Ulla M Weinreich, MD, PhD · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2025-09-30
Completion
2026-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257667 on ClinicalTrials.gov