Rehabilitation With HHFNC in COPD in Nocturnal NIV

NCT04683952 | Unknown

• 1 other identifier: FDG_HFNC_COPD_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Humidified High Flow Nasal Cannula (HHFNC), with optional supplemental oxygen delivery, has evolved in recent years with an increasing number of papers that show a better meet with respiratory demand, decrease oxygen dilution, increased Functional Residual Capacity (FRC), dead space washout, more tolerate than Non Invasive Ventilation (NIV) and provide heated and humidified gas. HHFNC is mainly used in intensive care settings or in acute respiratory diseases for the treatment of mild to moderate acute hypoxic respiratory failure and ventilator weaning. The aim of this study is to evaluate, in patients with Chronic Obstructive Pulmonary Disease (COPD) in nocturnal NIV, according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines, whether HHFNC during rehabilitation has an additional effect in increasing the distance in 6 Minute Walking Distance (6MWD) compared to the control group with nocturnal NIV without HHFNC treatment. As secondary objectives, we expect a decrease in Emergency Department (ED) accesses, General Practitioner (GP) unplanned visits, hospitalizations and an improvement of the quality of life and patient satisfaction.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; HHFNC; Chronic Obstructive Pulmonary Disease; Humidified High Flow Nasal Cannula; Non Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 6MWD

  The first outcome we expect to find is a change in the distance at 6-Minute Walking Distance (6MWD).

  "Baseline ( pre-intervention)" and "Immediately after the intervention".

Secondary Outcomes (1)

• Number of Exacerbations, GP visits and admission to ED and ICU

  Through study completion, an average of 1 year.

Other Outcomes (1)

• Points at Saint George Respiratory Questionnaire (SGRQ)

  "Baseline ( pre-intervention)" and "Immediately after the intervention".

Study Arms (2)

Rehabilitation with HHFNC

EXPERIMENTAL

15 Chronic Obstructive Pulmonary Disease patients in nocturnal Non Invasive Ventilation (NIV) who will perform rehabilitation, with / without Oxygen Therapy according to prescription, and with Humified High Flow Nasal Cannula (HHFNC). The Rehabilitation program consists in 20 session of 40 minutes, thrice a week for three times with a washout period of 3 months.

Device: Exercise training with Humified High Flow Nasal Cannula

Control Group rehabilitation without HHFNC

ACTIVE COMPARATOR

15 Chronic Obstructive Pulmonary Disease patients in nocturnal Non Invasive Ventilation (NIV) who will perform rehabilitation, with / without Oxygen Therapy according to prescription, without Humified High Flow Nasal Cannula (HHFNC). The Rehabilitation program consists in 20 session of 40 minutes, thrice a week for three times with a washout period of 3 months.

Other: Exercise training - Control Group

Interventions

Exercise training with Humified High Flow Nasal Cannula DEVICE

The experimental group will be trained using HHFNC with the most adequate continuous flow, in a range between 25 and 30 L / min.

Also known as: VEMO 150

Rehabilitation with HHFNC

Exercise training - Control Group OTHER

The control group will perform exercise training in spontaneous breathing.

Control Group rehabilitation without HHFNC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Chronic Obstructive Pulmonary Disease (post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \<0.7) ;
• Nocturnal Non Invasive Ventilation (NIV) prescription according to ATS/ERS guidelines with or without long-term oxygen therapy;
• Clinical stability (no exacerbation and no changing in respiratory drugs in the last 7 days);

You may not qualify if:

• Orthopedic or neurological pathologies that limit physical performance;
• Cognitive impairment (Mini-Mental State Examination \<24);
• Advanced heart disease, pulmonary fibrosis, participation in other clinical studies in the six months preceding the start of the study.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

RECRUITING

Related Publications (4)

• Schwabbauer N, Berg B, Blumenstock G, Haap M, Hetzel J, Riessen R. Nasal high-flow oxygen therapy in patients with hypoxic respiratory failure: effect on functional and subjective respiratory parameters compared to conventional oxygen therapy and non-invasive ventilation (NIV). BMC Anesthesiol. 2014 Aug 7;14:66. doi: 10.1186/1471-2253-14-66. eCollection 2014.

  PMID: 25110463 BACKGROUND

• Stephan F, Berard L, Rezaiguia-Delclaux S, Amaru P; BiPOP Study Group. High-Flow Nasal Cannula Therapy Versus Intermittent Noninvasive Ventilation in Obese Subjects After Cardiothoracic Surgery. Respir Care. 2017 Sep;62(9):1193-1202. doi: 10.4187/respcare.05473. Epub 2017 Aug 14.

  PMID: 28807988 BACKGROUND

• Hill K, Jenkins SC, Cecins N, Philippe DL, Hillman DR, Eastwood PR. Estimating maximum work rate during incremental cycle ergometry testing from six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2008 Sep;89(9):1782-7. doi: 10.1016/j.apmr.2008.01.020.

  PMID: 18760164 BACKGROUND

• 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.

  PMID: 31467119 BACKGROUND

Related Links

• The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Paolo Banfi, MD

  Fondazione Don C. Gnocchi - I.R.C.C.S. Santa Maria Nascente

  PRINCIPAL INVESTIGATOR

• Laila Di Pietro, RT

  Fondazione Don C. Gnocchi - I.R.C.C.S. Santa Maria Nascente

  STUDY CHAIR

Central Study Contacts

Paolo Banfi, MD

CONTACT

02 40308812; pabanfi@dongnocchi.it

Laila Di Pietro, RT

CONTACT

02 40308570; ldipietro@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: December 24, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 24, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)