High Flow in Interstitial Lung Disease

Lung Diseases, Interstitial Clinical Trial

— HiFloILD  

Official title:

The Effect of High Flow, Nasal Cannula Delivered Air in Patients With Interstitial Lung Disease - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03816722
• Other study ID #: N-20180070
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2023
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, 6 week cross-over study on the effect of High flow nasal cannula (HFNC) delivered air in patients with interstitial lung disease (ILD), in need of ambulatory oxygen therapy.

Primary outcome:

To investigate intra-personal differences in 6MWT, as well as SO2 and BORG score at the end of the 6MWT, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in SGRQ at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in quality of sleep, using the Richards-Campbell sleep questionnaire (RCSQ) at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in IC, at baseline, at 6 weeks and 12 weeks

Secondary outcome:

To investigate intra-personal differences in FVC, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in DLCO at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in mMRC-score at baseline, at 6 weeks and 12 weeks

Description:

In this pilot study we wish to investigate whether treatment with HFNC, delivered by MyAirvo2 (Fisher&Paykel, Auckland, New Zealand) in patients with interstitial lung disease (ILD) in need of ambulatory oxygen therapy (AOT).

Ten patients will be recruited from the outpatient clinic at Department of Respiratory Diseases, Aalborg University Hospital.

The study is carried out as a cross over study, randomizing 5 patients to intitially 6 weeks' HFNC treatment as add on to the patients' personalized usual care followed by 6 weeks observation on usual care and 5 patients to 6 weeks' observation on the patients' personalized usual care, followed by 6 weeks with HFNC as add on to usual care.

At inclusion patients' background information will be registered and patients will be examined with body plethysmography, registering TLC, FVC, RV and IC, as well as DLCO. Furthermore, a 6MWT will be performed, monitoring peripheral oxygen saturation (SO2)and BORG score at the beginning and the end of the procedure as well as analysis of arterial blood gasses (PaO2, PaCO2) at rest. In addition the modified Medical Research Council (mMRC)- score; the Richards-Campbell Sleep Questionaire (RCSQ) and the St. George Respiratory Questionaire (SGRQ) will be carried out at baseline. Following this, patients will be randomized to either usual care or usual care plus HFNC, recommended flow 30 liters/minute, recommended temperature 37o Celsius, recommended use 8 hours/day, preferably at night. After 6 weeks body plethysmography, 6MWT, mMRC, SGRQ, RCSQ and arterial blood gas analysis will be repeated and following this, treatment will cross over; as such, patients initially in the usual care arm will be treated with HFNC as add on according to the recommendations stated above and the previous HFNC treated group will be referred to usual care for the following 6 weeks. At the end of the study period (t=12 weeks), body plethysmography, 6MWT, mMRC, RCSQ, SGRQ and arterial puncture will be repeated in all patients as well as background information will be revisited to note any changes.

Should the patient reach chronic respiratory failure (saturation at rest < 88%) during the study period, patients will remain in study and the airflow during HFNC be oxygenated with whatever amount of oxygen is required to reach saturation >88% during High Flow treatment.

Equipment:

Heated, humidified, air will be delivered to the patients by MyAirvo 2 (Fisher&Paykel, Auckland, New Zealand). Patients will be treated with an intended flow of 30 L/min, intended use 8 hours per day, preferably nocturnal use. Should patients not tolerate the recommended flow, changes in flow are allowed. The Airvo2 device will be delivered and serviced in the patients' homes by VitalAire. Vitalaire will do readings of actual use on the device. At the end of the study, all patients will be offered continuous treatment with the device if so desired.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Age > 18 years old

• Patient diagnosed with interstitial lung disease

• Capable of understanding oral and written information and giving informed consent

• Newly diagnosed with need of oxygen during physical activity (SO2 <88%).

Exclusion criteria

• Pneumonia or exacerbation of ILD < 6 weeks prior to inclusion

• Other terminal disease than ILD and life expectancy < 3 months

• Patients not capable of understanding and accepting written or verbal information

• Patients with in need of continuous oxygen treatment at inclusion

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Device:
• Airvo2
Treatment with HighFlow through the Airvo2 device, 8 hours per day

Other:
• Usual care
High flow treatment is investigated as an add on treatment to the personalized care already prescribed to the patients. As patients with interstitial lung disease very often demand very different treatment set ups treatment will vary in the individual patients. All will, however, be treated with ambulatory oxygen. "Usual care" will be unaltered a month before inclusion in the study in each of the individual patients

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Fisher and Paykel Healthcare

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test	walking distance	change between 6 and 12 weeks
Primary	SO2	oxygen saturation of the blood	change between 6 and 12 weeks
Primary	modified BORG score	score of dyspnea, ranging 0-10 where 0 is no dyspnea	6 and 12 weeks
Primary	St George Respiratory Questionaire (SGRQ)	respiratory quality of life questionnaire, score with 20 questions all weighted in the final evaluation of the score. A change of 4 points is clinically relevant; a change of -4 an amelioration of quality of life	change between 6 and 12 weeks
Primary	Richards-Campbell's sleep questionnaire (RCSQ)	Quality of sleep questionnaire, based on 5 domains, evaluated individually by Visual Analog Scores(0-100), where 0 is the worst, 100 is the best outcome. All scores are equally weighted in the final score. The final, combined score is averaged, and expressed as a percentage of the total score	change between 6 and 12 weeks
Primary	inspiratory capacity	lung function measure (L, %)	change between 6 and 12 weeks
Secondary	Forced Vital Capacity	lung function measure (L, %)	change between 6 and 12 weeks
Secondary	diffusion capacity of the lung for carbon monoxide (DLCO)	diffusion capacity measure, (% of expected value)	change between 6 and 12 weeks
Secondary	modified Medical Research Council score (mMRC-score)	dyspnea-score, scoring from 0-4 points	change between 6 and 12 weeks