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Completed

NCT Number: NCT00901485

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

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.

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Key information

Conditions

Nocturnal Hypoventilation Chest Wall Disorder Hypercapnia Hypoventilation Hypoxia Nervous System Diseases Neuromuscular Disease Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AutoVPAP

Device

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

VPAPIIIST-A

Device

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

Primary outcomes

  1. Overnight Mean Oxygen Saturation

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Overnight Mean Transcutaneous Carbon Dioxide

    Time frame: 4 weeks

    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.

  2. Overnight Peak Transcutaneous Carbon Dioxide

    Time frame: 4 weeks

    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.

  3. Oxygen Desaturation Index (>4%)

    Time frame: 4 weeks

    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. Sleep Quality: Arousal Index

    Time frame: 4 weeks

    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)

Other outcomes

  1. Ventilator Adherence

    Time frame: 4 weeks

    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).

  2. Median Overnight Minute Ventilation

    Time frame: 4 weeks

    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).

  3. Median Overnight Pressure Support

    Time frame: 4 weeks

    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. Median Overnight Tidal Volume

    Time frame: 4 weeks

    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).

  5. Median Overnight Respiratory Rated

    Time frame: 4 weeks

    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).

  6. Subjective Ventilator Tolerance: Comfort of Breath Delivered

    Time frame: 4 weeks

    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)

  7. Subjective Ventilator Tolerance: Ease of Falling Asleep

    Time frame: 4 weeks

    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)

  8. Subjective Ventilation Tolerance: Ease of Use of Ventilator

    Time frame: 4 weeks

    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)

  9. Subjective Ventilator Tolerance: Liked Using Ventilator

    Time frame: 4 weeks

    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)

  10. Ventilator Mode Preference

    Time frame: 4 weeks

    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)

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 13, 2009
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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