Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients

Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation

The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Disease; Chest Wall Disorder; Nocturnal Hypoventilation
• Intervention / Treatment: Device: AutoVPAP; Device: VPAPIIIST-A

Detailed Description

The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (NIV). NIV is standard therapy for patients with nocturnal hypoventilation.

The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.

Patients over the age of 18 referred to, or under follow up at, the Royal Brompton Hospital who require domiciliary NIV but are inexperienced with use of NIV will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. At the end of one month the patient will be swapped to the alternative NIV for a further one month of domiciliary NIV treatment. At the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous CO2 monitoring and 24 hour Holter monitoring.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• new clinical diagnosis of nocturnal hypoventilation
• requirement for long-term domiciliary non-invasive ventilation
• no previous experience with domiciliary non-invasive ventilation

Exclusion Criteria:

• uncontrolled cardiac failure
• acute exacerbation of respiratory failure
• daytime resting PaO2 < 7.5kPa
• moderate or severe bulbar weakness
• inability to understand rationale and/or consent form for study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: autotitrating NIV; approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation	Device: AutoVPAP; Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.; Other Names: autotitrating variable positive airway pressure; autotitrating NIV; automatically titrating NIV
ACTIVE_COMPARATOR: Standard non-invasive ventilation; approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation	Device: VPAPIIIST-A; Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.; Other Names: standard NIV; standard non-invasive ventilator; variable positive airway pressure; VPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overnight Mean Oxygen Saturation	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overnight Mean Transcutaneous Carbon Dioxide	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.	4 weeks
Overnight Peak Transcutaneous Carbon Dioxide	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.	4 weeks
Oxygen Desaturation Index (>4%)	Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. ODI is the number of events per hour that SaO2 drops by >4%.	4 weeks
Sleep Quality: Arousal Index	A full PSG was performed during a sleep a on NIV at the end of each month's NIV therapy. Standard polysomnography analysis was performed by two team members blinded to patient identity and ventilator mode (REP/JJ). Sleep quality was assessed by the Arousal Index (no of arousals/hour)	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator Adherence	Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).	4 weeks
Median Overnight Minute Ventilation	Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).	4 weeks
Median Overnight Pressure Support	Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).	4 weeks
Median Overnight Tidal Volume	Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).	4 weeks
Median Overnight Respiratory Rated	Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak).	4 weeks
Subjective Ventilator Tolerance: Comfort of Breath Delivered	Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)	4 weeks
Subjective Ventilator Tolerance: Ease of Falling Asleep	Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)	4 weeks
Subjective Ventilation Tolerance: Ease of Use of Ventilator	Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)	4 weeks
Subjective Ventilator Tolerance: Liked Using Ventilator	Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)	4 weeks
Ventilator Mode Preference	Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive)	4 weeks

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: January 14, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (ESTIMATE): May 13, 2009

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Sleep; Polysomnography; Hypoxia; Hypercapnia; Hypoventilation; Titration; Respiratory insufficiency; Non Invasive Ventilation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation; Neuromuscular Diseases
• Other Study ID Numbers: 08/H0708/16; R&D No. 2008/LF017B (OTHER: Research & Development Department, RBH)