Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07065799

Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation

This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV), both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation.

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

COPD Chronic Disease Disease Attributes Exacerbation Copd Hypercapnia Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale S Donato, Arezzo, Italy

Loading trial locations.

About this study

This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV) both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation. The purpose of this study 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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • 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

  • BMI >30 kg/m2
  • 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

Treatment and study plan

Group 1: NHF/LTOT

Device

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

Device

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.

Primary outcomes

  1. Evaluation of the non-inferiority of the change in PaCO2 levels measured during treatment with NHF respiratory support compared to HMV respiratory support, both associated with standard oxygen therapy.

    Time frame: T0 (baseline), T1 (+3months), T2 (+6months)

    Unity of measurement: mmHg

Secondary outcomes

  1. Evaluation of the time required for setting up and adjusting the two respiratory strategies.

    Time frame: T0 (baseline), T1 (+3months), T2 (+6months)

    Unit of measurement: days

  2. Evaluation of PaO2 levels measured via arterial blood gas analysis

    Time frame: T0 (baseline), T1 (+3months), T2 (+6months)

    Unit of measurement: mmHg

  3. FVC, FEV1

    Time frame: T0 (baseline), T1 (+3months), T2 (+6months)

    Measured by spirometry Unit of measurement for FVC and FEV1: L

  4. Evaluation of exercise capacity measured using the 6-minute walk test (6MWT)

    Time frame: T0 (baseline), T1 (+3months), T2 (+6months)

    Unit of measurement: meters

  5. Evaluation of dyspnea measured using the Medical Research Council Dyspnea score

    Time frame: aT0 (baseline), T1 (+3months), T2 (+6months)

    mMRC score ranges from 0 to 4. 0=No dyspnea symptoms 4=severe dyspnea

  6. Evaluation of quality of life measured using the St. George's Respiratory Questionnaire

    Time frame: T0 (baseline), T1 (+3months), T2 (+6months)

    SGRQ's Total Score ranges between 0 and 100, where 0 is maximum quality of life and 100 is lowest quality of life

  7. Evaluation of quality of sleep measured using the Pittsburg Sleep Quality Index

    Time frame: T0 (baseline), T1 (+3months), T2 (+6months)

    PSQI ranges from 0 to 21, higher score indicate worse sleep quality

  8. Evaluation of compliance to respiratory supports measured by downloading usage data from the respiratory support.

    Time frame: T1 (+3months), T2 (+6months)

    Time of usage of the respiratory support in hours/day and hours/night.

  9. Evaluation of tolerance to respiratory supports meauserd using visual analog scales

    Time frame: T1 (+3months), T2 (+6months)

    Visual analog scale ranges between 0 to 10, 0=minimum tolerance 10=maximum tolerance

  10. Evaluation of frequency of exacerbations measured by counting the numbers of exacerbations occurred.

    Time frame: three, six and 12 month since the beginning of the treatment

    Unit of measurement: number of events

  11. Evaluation of severity of exacerbations and subsequent hospitalizations measured by counting the number of exacerbations that required hospitalizations

    Time frame: T1 (+3months), T2 (+6months) and T3 (+12months)

    Unity of measurement: number of exacerbation that required hospitalisation

  12. Evaluation of survival measured by mortality analysis

    Time frame: T1 (+3months), T2 (+6months) and T3 (+12 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Lara Pisani, Prof.ssa

CONTACT

[email protected]

0512143257

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Collaborators

  • Azienda Sanitaria dell'Alto Adige
  • Azienda Unita Sanitaria Locale di Piacenza
  • Fondazione Salvatore Maugeri
  • Ospedale San Donato
  • Policlinico Universitario, Catania

Registry information

Official study title

Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation: A Multicenter, Non-inferiority, Randomized, Crossover Study

Acronym: RESPHYC

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.