The Preference of Neuromuscular Patients Regarding Available Equipment for Daytime Mouthpiece Ventilation: a Randomized Cross-over Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Transcutaneous Carbon dioxyde
Study Overview
Brief Summary
BACKGROUND:
Patients with severe neuromuscular disorders (NMDs) are likely to develop progressive respiratory insufficiency, leading to noninvasive ventilation during the night and, later, during night and day. Ventilation via a mouthpiece (MPV) is an elegant option to offer daytime ventilation. The patient preference regarding the ideal material for daytime MPV is unclear.
OBJECTIVES:
The purpose of this study was to determine which ventilator, tubing support and mouthpiece was most effective and preferred by patients with NMDs.
METHODS:
Two separate MPV equipment sets were compared in 20 patients with NMDs in a randomized cross-over study. The first set consisted in a non-dedicated ventilator for MPV (PB560, Covidien) combined with a customized tubing support on the shoulders and a plastic angled mouthpiece. The second set included an MPV-dedicated ventilator (Trilogy 100, Philips Respironics) without back-up rate and kiss trigger combined with a commercially available tubing support and a silicone straw mouthpiece. The Borg dyspnea score, the free time without noninvasive ventilation, the transcutaneous oxygen saturation (SpO2) and carbon dioxide tension (TcCO2) were recorded without and with MPV. A 17-items list assessing the patient perception about MPV sets was completed.
Detailed Description
Materials and Methods
Aims
The primary aim of the study was to compare blood gas measurements, dyspnea score and general perception between the two sets for MPV. The second aim of the study was to determine the preference of patients on MPV equipment according to their free time. We also aimed at collecting individual comments of patients regarding their experience with the two ventilators, arm supports and mouthpieces.
Patients
All individuals affected by NMDs attending our Centre for Home Mechanical Ventilation between 2015 and 2018 who required daytime MPV as an extension of nocturnal NIV were considered for study inclusion. Our criterion for implementing daytime ventilation was the combined presence of increasing dyspnea and increasing workload on inspiratory muscles during the daytime (C) or, ultimately, daytime hypercapnia in the evening when patients lay in bed before starting nocturnal NIV and sleeping (M). All patients used Volume-Assisted Pressure Control mode (VAPC) at night via a Covidien Puritan Bennett PB560 ventilator (Covidien, Mansfield, USA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All individuals affected by NMDs attending our Centre for Home Mechanical Ventilation between January 2015 and December 2018 who required daytime MPV as an extension of nocturnal NIV
Exclusion Criteria
- •Patients with no need for daytime ventilation
- •patients with ineffective NIV during sleep as assessed by the measurement of TcCO2>49mmHg (S)
- •patients with uncontrollable oral leaks with MPV or episode of acute respiratory infection during the trials
Arms & Interventions
Ventilator PB560 (Covidien)
The non-dedicated (NON-DED) set comprised a ventilator for MPV (PB560) using a single active tubing with an exhalation valve. A custom-made arm support and plastic mouthpiece were used.
Intervention: Ventilator (Device)
Ventilator Trilogy (Philips Respironics)
The dedicated (DED) set comprised a ventilator for MPV (Trilogy 100, Philips Respironics; with dedicated software, with a single passive tubing without exhalation valve. A back-up rate set at zero cycle per minute was associated with a kiss trigger, with a smart flexible tube support system and with a silicone made mouthpiece designed as a straw.
Intervention: Ventilator (Device)
Outcomes
Primary Outcomes
Transcutaneous Carbon dioxyde
Time Frame: Day 3: continuous recording during trial 2 (30min)
Maximal level of CO2 tension in blood (PCO2)
Trancutaneous Oxygen saturation
Time Frame: Day 3: continuous recording during trial 2 (30min)
Minimal level of Oxygen saturation (SpO2)
Borg dyspnea score
Time Frame: Day 3: at the end of trial 2
Score (0-10 points; 0: very comfortable; 10: very uncomfortable) to evaluate the subjective feeling of breathing comfort. Borg is not an abbreviation but it is name of the author who validated the score. Dyspnea score is named "Borg" visual analogic score
A 17-item questionnaire assessing the patient perception
Time Frame: Day 3: at the end of trial 2
Score (0-5 points; 0: very bad ; 10: very good ) to evaluate the subjective perception (easiness-comfort) of patients with the ventilator equipment.
Secondary Outcomes
- Freetime(On day 1 (baseline))
Investigators
Kristien Mostinckx
Head of Rehabilitation Department
Revalidatieziekenhuis InkendaaI