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

NCT06257667 | Not Yet Recruiting

• 1 other identifier: N-20230045
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

high flow nasal cannula; duet nasal cannula

Outcome Measures

Primary Outcomes (2)

• Normalization of pH

  Number of patients with acute exacerbations of COPD including acute hypercapnic respiratory failure

  through study completion, a maximum of one week

• Time to normalization of pH

  Time till patients with acute exacerbations of COPD including acute hypercapnic respiratory failure normalize pH

  through study completion, a maximum of one week

Secondary Outcomes (1)

• Adherence to High Flow Nasal Cannula

  through study completion, a maximum of one week

Study Arms (2)

"OptiflowTM"

ACTIVE COMPARATOR

Patients treated with high flow nasal cannula, using the "OptiflowTM" Nasal Cannula

Other: Respiratory Support

"Optiflow+DuetTM"

EXPERIMENTAL

Patients treated with high flow nasal cannula using the "Optiflow+DuetTM" Nasal Cannula

Other: Respiratory Support

Interventions

Respiratory Support OTHER

Treatment with High Flow Nasal Cannula

"Optiflow+DuetTM"; "OptiflowTM"

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> 40 years old.
• A diagnosis of COPD, according to GOLD recommendations1, or clinical suspicion of COPD.
• Patients admitted with exacerbation, according to GOLD recommendations1, causing acute hypercapnic respiratory failure (pH≤7.35, pCO2 \>6.0 kPa) who do not tolerate NIV treatment.

You may not qualify if:

• Patients with acute hypercapnic respiratory failure caused by other diseases than COPD exacerbation, such as, but not limited to, acute heart failure, judged by the responsible clinician.
• Patients with combined metabolic- and respiratory acidosis (HCO3 \< 21.8 mmol/l, (female), 22.5 mmol/l, (male), and/or lactate \>2.5 mmol/l).
• Patients with terminal illness
• Patients who are incapable of giving informed consent.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Bispebjerg Hospital: collaborator
• Viborg Regional Hospital: collaborator

Related Publications (16)

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• Cammarota G, Simonte R, De Robertis E. Comfort During Non-invasive Ventilation. Front Med (Lausanne). 2022 Mar 24;9:874250. doi: 10.3389/fmed.2022.874250. eCollection 2022.

  PMID: 35402465 BACKGROUND

• Huang Y, Lei W, Zhang W, Huang JA. High-Flow Nasal Cannula in Hypercapnic Respiratory Failure: A Systematic Review and Meta-Analysis. Can Respir J. 2020 Oct 29;2020:7406457. doi: 10.1155/2020/7406457. eCollection 2020.

  PMID: 33178363 BACKGROUND

• Scala R. Challenges on non-invasive ventilation to treat acute respiratory failure in the elderly. BMC Pulm Med. 2016 Nov 15;16(1):150. doi: 10.1186/s12890-016-0310-5.

  PMID: 27846872 BACKGROUND

• Jeong JH, Kim DH, Kim SC, Kang C, Lee SH, Kang TS, Lee SB, Jung SM, Kim DS. Changes in arterial blood gases after use of high-flow nasal cannula therapy in the ED. Am J Emerg Med. 2015 Oct;33(10):1344-9. doi: 10.1016/j.ajem.2015.07.060. Epub 2015 Jul 30.

  PMID: 26319192 BACKGROUND

• Cortegiani A, Longhini F, Carlucci A, Scala R, Groff P, Bruni A, Garofalo E, Taliani MR, Maccari U, Vetrugno L, Lupia E, Misseri G, Comellini V, Giarratano A, Nava S, Navalesi P, Gregoretti C. High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial. Trials. 2019 Jul 22;20(1):450. doi: 10.1186/s13063-019-3514-1.

  PMID: 31331372 BACKGROUND

• Kim ES, Lee H, Kim SJ, Park J, Lee YJ, Park JS, Yoon HI, Lee JH, Lee CT, Cho YJ. Effectiveness of high-flow nasal cannula oxygen therapy for acute respiratory failure with hypercapnia. J Thorac Dis. 2018 Feb;10(2):882-888. doi: 10.21037/jtd.2018.01.125.

  PMID: 29607161 BACKGROUND

• Suzuki A, Ando M, Kimura T, Kataoka K, Yokoyama T, Shiroshita E, Kondoh Y. The impact of high-flow nasal cannula oxygen therapy on exercise capacity in fibrotic interstitial lung disease: a proof-of-concept randomized controlled crossover trial. BMC Pulm Med. 2020 Feb 24;20(1):51. doi: 10.1186/s12890-020-1093-2.

  PMID: 32093665 BACKGROUND

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Related Links

• Danish Respiratory Society Guideline on COPD exacerbation and NIV treatment
• Description of Optiflow plus Duet by manufacturer
• Definition of pack years

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Ulla M Weinreich, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulla M Weinreich, MD, PhD

CONTACT

+4597664735; ulw@rn.dk

Line H Storgaard, RN, MSc

CONTACT

+4597665980; line.storgaard@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: open label randomized controlled trial

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: February 14, 2024
• Study Start: March 31, 2024
• Primary Completion: September 30, 2025
• Study Completion: February 28, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share