Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation
NCT ID: NCT07065799
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
31 participants
INTERVENTIONAL
2024-06-30
2028-01-31
Brief Summary
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The purpose is to evaluate whether the clinical benefits, in terms of reduction in PaCO2 levels, resulting from the use of NHF are non-inferior to those obtained from the use of HMV.
Partecipants will be randomized at 1:1 ratio into two groups:
group 1: will start the respiratory strategy under study (NHF + standard oxygen therapy) as first treatment group 2 will start the control respiratory strategy (HMV + standard oxygen therapy) as first treatment.
The study has a crossover design: each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months
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Detailed Description
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Patients will be randomly assigned through a simple randomization list, stratified by recruiting center, generated by the Stata statistical software. Based on this list, patients will be divided into two groups: group 1 will start as the first treatment with the respiratory strategy under study (NHF + standard oxygen therapy) and group 2 will start as the first treatment with the control respiratory strategy (HMV + standard oxygen therapy). Randomization will occur at a 1:1 ratio. The study has a crossover design; each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months. To minimize the carry-over effect, a washout period of 7 days between respiratory supports will be scheduled. Therefore, considering the washout period, the total treatment duration is 25 weeks.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1
NHF/LTOT
Group 1: NHF/LTOT
Patients assigned to this group will start NHF (Nasal High Flow) + oxygen therapy at home and undergo a preliminary trial with NHF to set the optimal flow using the MyAIRVO 3 (Fisher \& Paykel Healthcare, Auckland, New Zealand) with Optiflow+Duet interface. Patients assigned to this group will be required to use NHF for a minimum of 6 hours per night during sleep, while no restrictions will be set on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the control respiratory strategy (HMV+LTOT) will begin.
Group 2
HMV/LTOT
Group 2: HMV/LTOT
Patients assigned to this group will start home treatment with HMV (Home Mechanical Ventilation) + oxygen therapy and will be treated with HMV using a pressure support (PS) ventilator. HMV will be administered via nasal mask or full face mask according to patients' preference. Patients assigned to this group will be required to use HMV for a minimum of 6 hours per night in addition to daily home oxygen therapy for at least 15 hours. Moreover, no restrictions will be imposed on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the studied respiratory strategy (NHF+LTOT) will begin.
Interventions
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Group 1: NHF/LTOT
Patients assigned to this group will start NHF (Nasal High Flow) + oxygen therapy at home and undergo a preliminary trial with NHF to set the optimal flow using the MyAIRVO 3 (Fisher \& Paykel Healthcare, Auckland, New Zealand) with Optiflow+Duet interface. Patients assigned to this group will be required to use NHF for a minimum of 6 hours per night during sleep, while no restrictions will be set on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the control respiratory strategy (HMV+LTOT) will begin.
Group 2: HMV/LTOT
Patients assigned to this group will start home treatment with HMV (Home Mechanical Ventilation) + oxygen therapy and will be treated with HMV using a pressure support (PS) ventilator. HMV will be administered via nasal mask or full face mask according to patients' preference. Patients assigned to this group will be required to use HMV for a minimum of 6 hours per night in addition to daily home oxygen therapy for at least 15 hours. Moreover, no restrictions will be imposed on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the studied respiratory strategy (NHF+LTOT) will begin.
Eligibility Criteria
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Inclusion Criteria
* Acquisition of informed consent form
* Patients with COPD
* Persistent hypercapnia (PaCO2 \>53 mmHg) 2-4 weeks after an acute hypercapnic exacerbation of COPD requiring NIV.
* pH value \>7.35.
* Chronic hypoxemia (PaO2 \<55mmHg or \<60mmHg if at least one of the following criteria is present: polycythemia, pulmonary hypertension or Chronic Pulmonary Heart Disease, \>30% of sleep time with SpO2 \< 90% measured with a pulse oximeter)
Exclusion Criteria
* Clinically significant obstructive sleep apnea syndrome (patients in whom there was a clinical suspicion of OSA syndrome based on clinical review or overnight oximetry will go further testing with limited respiratory polygraphy)
* Neuromuscular or chest wall diseases
* Need for intubation and invasive mechanical ventilation during exacerbation
* Use of home non-invasive mechanical ventilation or CPAP
* Contraindications for NIV
* Presence of cognitive impairment that would prevent informed consent into the trial
* Patients with active and unstable coronary artery syndrome
* Patients suffering from malignancies
18 Years
90 Years
ALL
No
Sponsors
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Azienda Sanitaria dell'Alto Adige
OTHER
Ospedale San Donato
OTHER
Azienda Unita Sanitaria Locale di Piacenza
OTHER
Policlinico Universitario, Catania
OTHER
Fondazione Salvatore Maugeri
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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dr. Stefano Nava
Prof.
Principal Investigators
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Lara Pisani, Prof.ssa
Role: PRINCIPAL_INVESTIGATOR
University of Bologna
Locations
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Ospedale S Donato
Arezzo, , Italy
Bolzano Hospital
Bolzano, , Italy
Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-Sn Marco"
Catania, , Italy
ICS Maugeri Spa Società Benefit IRCCS
Pavia, , Italy
Azienda Unità Sanitaria Locale
Piacenza, , Italy
Countries
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Central Contacts
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Facility Contacts
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Raffaele Scala
Role: primary
roberto dongilli
Role: primary
Claudia Crimi
Role: primary
Annalisa Carlucci
Role: primary
Cosimo Franco
Role: primary
References
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Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451.
Ergan B, Oczkowski S, Rochwerg B, Carlucci A, Chatwin M, Clini E, Elliott M, Gonzalez-Bermejo J, Hart N, Lujan M, Nasilowski J, Nava S, Pepin JL, Pisani L, Storre JH, Wijkstra P, Tonia T, Boyd J, Scala R, Windisch W. European Respiratory Society guidelines on long-term home non-invasive ventilation for management of COPD. Eur Respir J. 2019 Sep 28;54(3):1901003. doi: 10.1183/13993003.01003-2019. Print 2019 Sep.
Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
Storgaard LH, Hockey HU, Laursen BS, Weinreich UM. Long-term effects of oxygen-enriched high-flow nasal cannula treatment in COPD patients with chronic hypoxemic respiratory failure. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1195-1205. doi: 10.2147/COPD.S159666. eCollection 2018.
Weinreich UM, Juhl KS, Soby Christophersen M, Gundestrup S, Hanifa MA, Jensen K, Andersen FD, Hilberg O, Storgaard LH. The Danish respiratory society guideline for long-term high flow nasal cannula treatment, with or without supplementary oxygen. Eur Clin Respir J. 2023 Feb 23;10(1):2178600. doi: 10.1080/20018525.2023.2178600. eCollection 2023.
Pisani L, Vega ML. Use of Nasal High Flow in Stable COPD: Rationale and Physiology. COPD. 2017 Jun;14(3):346-350. doi: 10.1080/15412555.2017.1315715. Epub 2017 May 1.
Other Identifiers
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n° 22/2024/Disp/AOUBo
Identifier Type: -
Identifier Source: org_study_id
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