High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)

High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01214200

Acronym

HINPPV

Enrollment

Registered

2010-10-04

Start date

2010-08-31

Completion date

2012-12-31

Last updated

2019-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Brief summary

The purpose of this pilot study is to evaluate the effect of high intensity non-invasive positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will benefit the stable hypercapnic COPD patient through a reduction in the daytime partial pressure of carbon dioxide in arterial blood (PaCO2) levels.

Detailed description

The High Intensity Non-invasive Positive Pressure trial is a single arm interventional study. The purpose of this study is to evaluate the effect of High Intensity Non-invasive ventilation (HINPPV) in stable Chronic Obstructive Pulmonary patients with chronically elevated carbon dioxide levels. Participants will undergo various testing ( arterial blood gas (ABG), Pulmonary Function Test (PFTs), Polysomnography (PSGs), 6 minute walk tests)over a 3 month period to determine if this type of therapy will improve daytime carbon dioxide levels. The participants will also complete quality of life questionnaires to help ascertain improvements in their daily living activities.

Interventions

DEVICEBilevel positive airway pressure (BiPAP)

This is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation(HINPPV). Participants will receive HINPPV via bilevel positive airway pressure (BiPAP) via a Synchrony ventilator if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 80 Years

Healthy volunteers

Inclusion criteria

1. Patient diagnosed with chronic obstructive pulmonary disease (COPD) 2. Age \< or = to 80 years 3. Forced expiratory volume in one second (FEV1) \< 50% of predicted value 4. FEV1/Forced vital capacity (FVC) \< 70% of predicted value 5. Total lung capacity (TLC) \> 90% predicted by plethysmography 6. Body Mass Index (BMI) \< 35 7. Patient has provided written informed consent using a form that has been approved by the Internal Review Board (IRB) 8. Daytime PaCO2 ≥ 52 mm Hg, at rest on room air (Denver \> 48 mm Hg) with one of the following symptoms of hypercapnia: * Fatigue * Sleepiness * Headaches 9. Post hospital discharge at least one month prior to screening visit 10. Participant is willing and able to complete all required assessments and procedures 11. Participant has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential

Exclusion criteria

1. FEV1 \< 15% of predicted value 2. Diagnosis of obstructive sleep apnea (OSA) \[Apnea hypopnea index (AHI) \> 15 per hour\] 3. Current Non-invasive Positive Pressure Ventilation (NIPPV), Positive Airway Pressure (PAP) or Non-invasive Ventilation (NIV) users 4. Signs / symptoms of acute exacerbation within the previous month: two of the following criteria: * Increasing cough * Purulent sputum * Current use of antibiotics * pH \< 7.35 5. Any major non COPD disease or condition that interferes with completion of initial or follow-up assessments, such as uncontrolled malignancy, end-stage heart disease, liver or renal insufficiency (that requires current evaluation for liver or renal transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or other as deemed appropriate by investigator as determined by review of medical history and / or patient reported medical history 6. History of pneumothorax 7. Anatomical facial abnormalities precluding placement of a nasal or facial mask 8. Diffuse parenchymal lung disease other than emphysema 9. Inability to maintain Oxygen (O2) saturation \>90% on 5L/min ( five liters) nasal O2 at rest 10. Sustained need for \>10 mg prednisone daily or equivalent dose of other systemic corticosteroid 11. Pregnancy 12. Excessive alcohol intake (≥ 6oz hard liquor daily), or illicit drug use 13. Daily use of narcotics (greater than 30 mg morphine equivalent) 14. Patient is currently enrolled in another interventional clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)	Before and after 3 months of therapy	Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.

Secondary

Measure	Time frame	Description
Maximal Inspiratory Pressure	Before and after 3 months of therapy	The Maximal inspiratory pressure (MIP) is the maximum negative pressure that can be generated from one inspiratory effort starting from functional residual capacity (FRC) or residual volume (RV). This was assessed at baseline and after 3 months of therapy.
Exercise Capacity	Before and after 3 months of therapy	Exercise capacity will be measured by comparing the 6 minute walk test as measured in meters from baseline to 3 months
Dyspnea at Rest and With Exertion	Before and after 3 months of therapy	The modifed Borg scale was used to measure dyspnea. The Dyspnea Borg scale measures patients perceived level of dyspnea. The scale ranges from 0 to 10, 0- nothing at all and 10 is maximal.
Health Status	Before and after 3 months of therapy	Health status was assessed by completing different surveys at baseline and after 3 months of therapy. The Calgary Sleep Apnea Quality of Life was administered at baseline and 3 months. It is a 35-item, interview-administered scale, the SAQLI evaluates four domains of quality of life associated with sleep apnea: daily functioning, social interactions, emotional functioning, and symptoms. The SAQLI use a 7-point Likert scale ranging from 1 (maximal impairment) to 7 (no impairment).
Duration of Sleep	Before and after 3 months of therapy	Duration of sleep will be measured using total sleep time. Total sleep time is the overall number of minutes of sleep, this will be compared from baseline to 3 months.
Efficiency of Sleep	Before and after 3 months of therapy	Sleep efficiency will be measured by taking the total sleep time by the total time in bed. This is measured as a percentage and compared from baseline to 3 months
Sleepiness	Before and after 3 months of therapy	Sleepiness will be evaluated by measuring the the baseline and 3 month Epworth Sleepiness Scale. The Epworth Sleepiness Scale is an 8 question survey regarding daytime sleepiness. The higher the score the higher the chance of dozing during the day. Each question is rated on a 0 to 3 scale of chance of dozing or sleeping. 0 would be no chance, 3 would be the highest chance.

Countries

United States

Participant flow

Participants by arm

Arm	Count
High Intensity Non Invasive Pos.Pressure The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.	9
Total	9

Arm

Count

High Intensity Non Invasive Pos.Pressure

The High Intensity Non-invasive Positive Pressure (HINPPV) trial is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive HINPPV) for 90 days. Participants will receive HINPPV via bilevel positive airway pressure (BiPAP Synchrony) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Did not meet inclusion/exclusion	9
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	High Intensity Non Invasive Pos.Pressure
Age, Continuous	64.4 years STANDARD_DEVIATION 6.6
BMI	26.6 kg/m^2
Cigarette Usage	55 packs per year
Forced Expiratory Volume 1 sec (FEV1s)	26 percent of predicted STANDARD_DEVIATION 6.73
Region of Enrollment United States	9 Participants
Sex: Female, Male Female	7 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 9
other Total, other adverse events	0 / 9
serious Total, serious adverse events	4 / 9

Outcome results

Primary

Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)

Daytime PaCO2 levels assessed after using high intensity non-invasive positive pressure ventilation (HINPPV) are compared to the participants' baseline daytime PaCO2 levels.