Neuromuscular Diseases Clinical Trial
Official title:
The Preference of Neuromuscular Patients Regarding Available Equipment for Daytime Mouthpiece Ventilation: a Randomized Cross-over Study
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.
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).
Exclusion criteria comprised 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. The current study was approved by the local
ethics committee and registered (N° registered study. Clinical trial.org follows). The
patients gave their written informed consent before study inclusion.
Study design
The study design consisted in a randomized cross-over study. Patients served as their own
control. Measurements were made during a 48-hour hospitalization that is scheduled every 6
months in patients attending our Centre for Home Mechanical Ventilation. Hospitalization
systematically included nocturnal recordings of transcutaneous carbon dioxide tension (TcCO2)
and pulse oximetry (SpO2). Randomized trials were decided by toss and tested during a 1-hour
session of assisted breathing via MPV on two separate days. Patients were seated in their
wheelchair and trials started with connecting patients to transcutaneous TcCO2 and SpO2
measurements.
Equipment for MPV
Two different MPV equipment sets were compared (figure 1). Each set included separate
ventilators, tubing supports and mouthpieces. Both ventilators used volume assisted control
mode (VAC) according to the patient preference reported in a previous study (Q).
The first set consisted in a non-dedicated (NON-DED) ventilator for MPV (PB560) using a
single active tubing with an exhalation valve. The trigger was set on high sensitivity.
Solutions to avoid nuisance from disconnection alarms were used according to a report from
Boitano and colleagues (O). The PB560 was combined with a local custom-made tubing support in
thermo-formable plastic U-piece placed on the patient shoulders (figure 1 A) described in a
previous report (M). The mouthpiece consisted in a 22mm white angled hard plastic mouthpiece
(Philips Respironics; Murrysville, USA). Despite being a non MPV-dedicated set, the NON-DED
set was previously reported as safe and an effective (M).
The second set included an MPV-dedicated (DED) ventilator (Trilogy 100, Philips Respironics;
Murrysville, USA) with an MPV dedicated software with disconnection alarms switched off. This
set included a single passive tubing without exhalation valve. A back-up rate set at zero
cycle per minute was associated with a kiss trigger. The kiss trigger consisted in a
sensitive flow detection system allowing on-demand ventilation via a constant airflow
produced by the ventilator. When this constant flow was disrupted by the engagement and
disengagement of the patient's lips from the mouthpiece, a single inspiratory cycle was
triggered. Finally, the DED equipment included a smart flexible tube support system attached
via a wedge on the patient's wheelchair (figure 1 B). The tubing ended with a silicone made
mouthpiece designed as a straw. The backup rate in de DED equipment was copied from nighttime
values. Similar VAC mode, tidal volumes and inspiratory times were used in both equipment's
to facilitate further comparison. Trials were a succession of intermittent
disconnections-reconnections to the mouthpiece. All patients were encouraged to manage leaks
around the mouthpiece according to their breathing comfort.
Measurements
Day 1
Forced vital capacity (FVC), maximal inspiratory (MIP) and expiratory pressures (MEP) were
measured on the first day in seated position as per ATS/ERS guidelines (T) via a heated
Fleisch no. 2 pneumotachometer (Metabo, Lausanne, Switzerland). The Borg dyspnea scale on 10
points reflecting the degree of comfortable breathing was also recorded on the first day (C).
Other daytime baseline measurements such as transcutaneous oxygen saturation (SpO2) and
carbon dioxide tension (TcCO2) were recorded without daytime ventilation via an ear clip
connected to a Sentec monitoring (SenTec AG, Therwil, Swizerland). This technique was
validated for continuous monitoring of PaCO2 during sleep in this group of patients (U). The
participants were asked to determine their free time defined as the time of comfortable
spontaneous breathing without NIV. Finally, the maximal active mouth opening (space between
upper and lower teeth) was measured.
Day 2 and 3
The maximal TcCO2 and minimal SpO2 values obtained during the trials were measured. As in day
1, the Borg dyspnea score was recorded to evaluate the breathing comfort during MPV trials. A
17-items list assessing the patient perception with a Likert scale ranging from 0 to 5 (0:
maximal dissatisfaction, 5: maximal satisfaction) was completed during the trials.
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