Nasal High-Flow in COPD (High-TeC)
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|ClinicalTrials.gov Identifier: NCT03564236|
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : June 28, 2018
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations.
Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown.
Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT.
Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating.
Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included.
Intervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care.
Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Device: Nasal High Flow Therapy Other: Standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Paralell-group randomised controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Nasal High-Flow Therapy to Treat COPD Exacerbations: a Matter of Monitoring and Controlling Settings?|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Active Comparator: Standard Care
Standard care is provided according to our local COPD exacerbation protocol. All patients are treated with:
Other: Standard care
Standard regular care of a COPD exacerbation
Experimental: Nasal High Flow Therapy
In addition to the standard care described above, patients in the intervention group will be treated with:
Device: Nasal High Flow Therapy
Nasal High Flow Therapy (nHFT) is an innovative therapy for patients with respiratory diseases. It supplies heated, humidified, and oxygen-enriched air at high flow rates through a nasal cannula. Because the air is provided through an open system with a nasal cannula, it is relatively easy to apply and suggested to be very comfortable for patients. The technique has been shown to be effective in the treatment of hypoxemic respiratory failure, mainly in neonates and patients with acute hypoxemic respiratory failure on intensive care units (ICU).
- Health-Related Quality of Life [ Time Frame: 90 days ]The primary outcome will be improvement in HRQoL, defined as the net response rate on the St. George Respiratory questionnaire (SGRQ) after 90 days
- Treatment failure [ Time Frame: 90 days, follow-up up to 1 year ]Treatment failure of nHFT, defined as death, need for intensive care admission for respiratory failure, need for (non)-invasive mechanical ventilation, during the study period, in patients randomised to nHFT.
- Hospitalisations [ Time Frame: 90 days, follow-up up to 1 year ]Hospital length of stay of the index admission, readmissions, readmission characteristics and complications.
- Exacerbation frequency [ Time Frame: 90 days, follow-up up to 1 year ]Exacerbations will be defined as periods of symptom worsening treated with oral prednisolone and/or antibiotics.
- Severe Respiratory Insufficiency Questionnaire (SRI) [ Time Frame: 90 days ]Subjective recovery during hospitalisation and thereafter will also be investigated by assessing the Severe Respiratory Insufficiency Questionnaire (SRI). This is a well-known and validated Health-Related quality of Life (HRQoL) questionnaire especially designed for patients with chronic hypercapnic respiratory failure containing 49 items measuring 7 conceptual domains of HRQoL: respiratory complaints, physical functioning, attendant symptoms and sleep, social relationships, anxiety, psychological well-being and social functioning, and a summary score. The domain scores are calculated by transforming the mean item score into a percentage ranging from 0 (most severely depressed health status as complaints/limitations are severe) to 100 (perfect health status with no complaints/limitations).
- Clinical COPD Questionnaire (CCQ) [ Time Frame: 90 days ]Subjective recovery during hospitalisation and thereafter will be also investigated by assessing the Clinical COPD Questionnaire (CCQ). The CCQ is a disease specific but not "respiratory failure" specific questionnaire. It is a 10-item, self-administered questionnaire that can be completed in less than 2 minutes, and as so, is an attractive measure to be performed repeatedly during an exacerbation. Items are divided into three domains: symptom, functional state and mental state; patients are required to respond to each item on a seven-point Likert scale where 0 = asymptomatic/no limitation and 6 = extremely symptomatic/total limitation. The final score is the mean of all ten items, and scores for the three domains can be calculated separately if required.
- Euroqual-5 Dimensions questionnaire (EQ-5D) [ Time Frame: 90 days ]
Subjective recovery during hospitalisation and thereafter will also be investigated by assessing the EQ-5D. The EQ-5D questionnaire is made up for two components; health state description and evaluation. In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using five-level (EQ-5D-5L) scale.
In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), ranging from 0 to 100.
EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, will be converted in index values, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions, according to the guideline (https://euroqol.org).
- Cough and Sputum Assessment Questionnaire (CASA-Q) [ Time Frame: 90 days ]Subjective recovery during hospitalisation and thereafter will also be investigated by assessing the Cough and Sputum Assessment Questionnaire (CASA-Q). CASA-Q score is a tool for evaluating cough and sputum and their impact on patient's QOL in COPD. CASA-Q consists of two cough domains; the cough symptom domain (COUS, 11 items) and the cough impact domain (COUI, 8 items), and two sputum domains; the sputum symptom domain (SPUS, 3 items) and the sputum impact domain (SPUI, 16 items). All items will be scored from 0 to 4, such that the score was 0-12 for COUS and SPUS, and 0 to 24 for SPUI, and 0 to 32 for COUI, and each item summed and rescaled using the following algorithm: (sum rescored items)/(range of rescored item sum) x 100 (%). This results in CASA-Q scores that range from 0 to 100, with higher score associated with fewer symptoms and less impact due to cough and sputum.
- Gas exchange [ Time Frame: 90 days ]Gas exchange will be monitored with both arterial blood gases during spontaneous breathing at daytime and nocturnal transcutaneous monitoring while on the prescribed therapy.
- Functional capacity [ Time Frame: discharge and after 90 days ]Functional capacity will be assessed at discharge and 90 days thereafter (T1 and T3) by means of calculating daily activity level, measured with a step counter
- Assessment of cardiac function [ Time Frame: 90 days ]An electrocardiogram (ECG) and blood pressure measurements will be performed. The N-terminal of the brain natriuretic peptide (NTproBNP) will be assessed by routine laboratory methods.
- Compliance [ Time Frame: 90 days ]Compliance with the nHFT device will be read out from the compliance logs stored in the device when patients visit the outpatient clinic.
- Cost-effectiveness [ Time Frame: 90 days ]Cost-effectiveness will be investigated by estimating the healthcare costs of nHFT and usual care and the HRQoL gains of usual care and nHFT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564236
|Contact: Marieke L Duiverman, MD PhDfirstname.lastname@example.org|