Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation

Not Applicable

Recruiting

• Conditions: COPD; Hypercapnia; Exacerbation Copd

• Registration Number: NCT07065799
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-05-17
• Study Start: 2024-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2027-12
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.	T0 (baseline), T1 (+3months), T2 (+6months)	Unity of measurement: mmHg

Secondary Outcome Measures

Name	Time	Method
Evaluation of the time required for setting up and adjusting the two respiratory strategies.	T0 (baseline), T1 (+3months), T2 (+6months)	Unit of measurement: days
Evaluation of PaO2 levels measured via arterial blood gas analysis	T0 (baseline), T1 (+3months), T2 (+6months)	Unit of measurement: mmHg
FVC, FEV1	T0 (baseline), T1 (+3months), T2 (+6months)	Measured by spirometry Unit of measurement for FVC and FEV1: L
Evaluation of exercise capacity measured using the 6-minute walk test (6MWT)	T0 (baseline), T1 (+3months), T2 (+6months)	Unit of measurement: meters
Evaluation of dyspnea measured using the Medical Research Council Dyspnea score	aT0 (baseline), T1 (+3months), T2 (+6months)	mMRC score ranges from 0 to 4. 0=No dyspnea symptoms 4=severe dyspnea
Evaluation of quality of life measured using the St. George's Respiratory Questionnaire	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
Evaluation of quality of sleep measured using the Pittsburg Sleep Quality Index	T0 (baseline), T1 (+3months), T2 (+6months)	PSQI ranges from 0 to 21, higher score indicate worse sleep quality
Evaluation of compliance to respiratory supports measured by downloading usage data from the respiratory support.	T1 (+3months), T2 (+6months)	Time of usage of the respiratory support in hours/day and hours/night.
Evaluation of tolerance to respiratory supports meauserd using visual analog scales	T1 (+3months), T2 (+6months)	Visual analog scale ranges between 0 to 10, 0=minimum tolerance 10=maximum tolerance
Evaluation of frequency of exacerbations measured by counting the numbers of exacerbations occurred.	three, six and 12 month since the beginning of the treatment	Unit of measurement: number of events
Evaluation of severity of exacerbations and subsequent hospitalizations measured by counting the number of exacerbations that required hospitalizations	T1 (+3months), T2 (+6months) and T3 (+12months)	Unity of measurement: number of exacerbation that required hospitalisation
Evaluation of survival measured by mortality analysis	T1 (+3months), T2 (+6months) and T3 (+12 months)

Trial Locations

Locations (5)

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