Autor : Blanco Magalà 1,2 Ernst Glenda2,3 Salvado Alejandro1 Borsini Eduardo1,2
1Center for Respiratory Medicine. Hospital Británico de Buenos Aires 2Sleep and Ventilation Unit. Hospital Británico de Buenos Aires 3Scientific Advisory Committee. Education and Research Hospital Británico de Buenos Aires
Correspondencia :
Abstract
Introduction: Treatment with positive pressure may cause adverse effects. In order to
know the compliance and intolerance profile, we analyzed the behaviors
established by physiotherapists of a Sleep Unit.
Materials and Methods: Observational, retrospective, cross-sectional study. We included
patients older than 18 years with positive pressure referred to the kinesiological consultation.
Results: 244 patients were evaluated during four years: 165 men (67%), age 65.7 ±
11.6 years, BMI (Body Mass Index) 31.0 ± 5.4 (kg/m2), 61% of which used fixed
CPAP (Continuous Positive Airway Pressure), 29% auto-adjusting CPAP, 8% bilevel devices, 147 (60%) nasal masks, 52 (21%) oronasal masks; 37 pads (15%), and 92 (36%) thermohumidifiers.
Reasons for consultation were:
therapy control, 239 (61%); intolerance, 67 (17%), and calibration, 51 (13%).
Compliance (hours/night) was 4.61
± 2.1, with a percentage of nights > 4 hours of 67 ± 36%. We didn’t find any
difference in the comÂpliance of the first and the second year (4.5 vs. 5.0
hours/night) p > 0.13, but the value was higher after 600 days of therapy (p
< 0.05).
141 patients (57%) showed some
complications, the most frequent being leaks (19%) or intolerance to the masks
(10%). 97% of the patients resolved the intolerance with 194 behaviors:
explanation of how to use the mask, 94 (48%); calibration, 44 (22%);
information, 45 (23%); titration, 13 (6%), and referral to the pulmonologist,
14 (7%).
Conclusions: Two thirds of the patients complied with the positive pressure treatment
and half of the patients showed intolerance. The specialized kinesiological consultation can contribute to the
identification and resolution of difficulties that may arise during therapy.
Key words: Sleep apnea syndrome, CPAP treatment, Adherence
Recibido: 06/30/2020
Aceptado:
11/08/2020
Introduction
CPAP therapy is the first-line
treatment of moderate and severe sleep apneas of obstructive mechaÂnisms (OSA)1-2.
Its efficacy depends on the compliance and intolerance of multifactor
origin, which are frequent in the initial phases of treatment3-7.
A multidisciplinary team is
essential to contribute to the treatment with continuous positive airway
pressure (CPAP) in patients with sleep-related breathing disease. Personalized
care and a precision medicine approach determine that the treatment should take
into account the preferences and indiÂvidual responses to treatment8-13.
Various studies show that health
professionals other than physicians may have a broad and diverse role during
follow-up and clinical management of patients with OSA or patients who require
CPAP or noninvasive ventilation (NIV)8-12. The education of
patients and treatment follow-up are important tasks in this regard10-12,
as well as the identification and resolution of the main
secondary effects3, 12, 13.
On the other hand, the CPAP
devices record data that allow for the evaluation of the patients’ perÂformance
by monitoring compliance, leaks, the level of therapeutic pressure and residual
events. This is a useful way of evaluating efficacy with time
and through different interventions8-14 and the devices are
crucial to the identification of intolerance.
With the aim of knowing the level
of compliance, the consultation profile, and causes of intolerance, we proposed
to analyze the behaviors determined in a Sleep Unit through a specialized
consultation unit conducted by physiotherapists.
Objectives
– To know the level of
compliance, the causes of intolerance to CPAP treatment and the behaviors
determined for its resolution.
Materials and Methods
Study Design
Observational,
retrospective, cross-sectional study in only one center.
We reviewed systematically
collected data of outpatient consultations between January 2016 and January
2020, obtained from a medical office specialized in CPAP adaptation and
follow-up that belongs to the Sleep Unit of a community hospital.
This study was approved by the
Institutional Review Board of the Hospital Británico
(CRIHB, for its acronym in Spanish) in accordance with the ethical principles
of the Declaration of Helsinki and successive amendments (CRIHB #1030 protocol,
approved on 15 August, 2020).
Population
The study included OSA patients
older than 18 years who were evaluated in the sleep medicine speÂcialized
consultation unit coordinated by a respiratory physiotherapist. Patients were
referred for monitoring of CPAP treatment, education and training in the use of
the device or demonstration of how to use the interfaces.
We took into account the consultation
of patients without previous experience and also those who had completed the
adaptation; also, patients diagnosed with obesity hypoventilation syndrome,
periodic breathing and those requiring other modes of treatment with positive
pressure (ventilation with two levels of pressure, servo-controlled
ventilation).
During the daily physiotherapist
consultation, the indication of CPAP therapy or noninvasive venÂtilation given
by the respective attending pulmonologists was kept the same with no modification
or intervention, as usually happens in our Sleep Unit.
Patients who didn’t need positive
pressure treatment or suffered another sleep-related, non-respiÂratory disease
were excluded.
Information regarding compliance, efficacy and tolerance to CPAP/NIV
therapy
The baseline Apnea-Hypopnea Index
(AHI) was obtained from the polysomnography (PSG) or
respiratory polygraphy (RP) records, and the Body
Mass Index (BMI) was registered from the sleep study reports.
We took into consideration the
information received during the patients’ consultation with regard to: reason
for consultation, duration of therapy, mean use and percentage of nights with
> 4 hours’ use in the last 30 days, and intolerance events related to the
devices told by each patient (pressure, auto-perceived leaks and humidification
level of inhaled air).
Objective follow-up data were
obtained from the information downloaded from the devices’ memory (SD Card) by
means of the following software: Encoreâ„¢ Pro II Philips-Respironicsâ„¢,
ResScanâ„¢ of ResMedâ„¢, ResSmartâ„¢ of BMC Medicalâ„¢, or else by means of the online
Air Viewâ„¢ platform (remote monitoring) of ResMedâ„¢.
We confirmed the masks that were
used and the main adverse effects or lesions related to the inÂterfaces.
Information about the effective
pressure was obtained from the visual analysis of the pressure/time curve. When
available, data regarding compliance, mean leaks and residual apnea-hypopnea
index (rAHI) were registered in events per hour (ev/h).
Statistical Analysis
Data were presented as
percentages of the categorical variables. Continuous variables with normal
distribution are expressed as number and percentage (n; %) or mean and standard
deviation; and variables without normal distribution are expressed as median
and percentile (25-75%).
For the comparison of
differences, we used the Mann-Whitney or Fisher tests or χ2, depending on the
type of variables. For the comparison of different therapy pressures, we carried
out a linear regression analysis. For the statistical analysis we used Graph
Pad Prism-8.02â„¢ software.
Results
244 patients were evaluated in
388 visits for four years. 165 patients were men (67%); age, 65.7 ± 11.6 years,
BMI (kg/m2) 31.0 ± 5.4. Table
1 summarizes the characteristics of the study population.
The diagnosis was established by polysomnography (43%), home respiratory polygraphy
(50%) or both (6%). Six patients showed mild OSA (2%), 66 (27%) had moderate
OSA and there were 155 cases (63%) of severe OSA. 7% were respiratory
sleep-related diseases other than OSA.
At the moment of the
consultation, 61% of patients used fixed pressure CPAP, 29% auto-adjusting CPAP
and 8% bilevel devices. At the moment of the
evaluation, 147 patients used nasal masks (60%); 52 oronasal
masks (21%); 37 pads (15%), and 92 patients (36%) used thermohumidification
systems.
53 (21%) patients had undergone more
than 1 year of treatment with positive pressure devices; less than one year,
102 patients (41%); and 89 patients started treatment with kinesiological
support (36%).
After analyzing the visits (more
than one per patient), we found out that the reasons for consultaÂtion were
mainly therapy control (239; 61%), intolerance (67; 17%) and CPAP calibration
(51; 13%). Table 2 shows the reasons for referral and initial
consultation.
Compliance with positive pressure
treatment (hours/night) was 4.6 ± 2.1, with a proportion of nights > 4 hours
of use for 30 days before consultation of 67 ± 36%. 94 patients (38%) showed
compliance with > 75% of the nights. (Table 3)
We didn’t find any difference in
compliance when comparing the first and second year of CPAP use (4.5 vs. 5.0
hours/night) p > 0.13 (Figure 1). However, the percentage of nights
using the device > 4 hours was higher relating to longer duration of
therapy, evidencing this difference 600 days after startÂing the treatment (Figure
2) p < 0.05.
141 patients (57%) showed
intolerance, most frequently leaks (42; 19%) and events related to the mask or thermohumidification (Table 4 and Figure 3). In 138
cases (97%), the intolerance could be identified and resolved during the kinesiological consultation.
Within the group with > 1 year
of treatment (n; 53), 36 patients showed intolerance (67%), though 34 (64%)
complied with the therapy more than 4 hours/night and 30 (56%) complied with
> 4 hours of use, > 75% of the nights, within 30 days before
consultation. (Table 5)
Finally, 194 behaviors were
determined for the resolution of intolerance events detailed in Table 6.
Discussion
This work exposes the complexity
of OSA patients’ follow-up during treatment with positive airway pressure.
In our population, one third of
patients with CPAP required interventions related to the device or the mask, or
needed guidance to follow the treatment, or solve the intolerance or the
treatment’s adverse effects.
In OSA patients who are in the
adjustment or follow-up phase, the work model of our unit takes into account
the participation of the respiratory physiotherapist with bi-directional
referral to and from the pulmonologist. Mid-term follow-up (the first six
months) is the period in which the main secondÂary effects
are produced, which, if adequately resolved, determine success in terms
of acceptance and maintenance of therapy in the long-term12. The
role of the non-medical staff at the Sleep Unit may be a control point in the
semiology of the patient and his/her equipment, and include sleep lab
technicians, nurses and physiotherapists.
In this cohort of patients,
compliance was acceptable (near 70%), with a mean use > 4 hours/night
similar to that described in other works, both national and international16-20.
However, thanks to specialized consultations it was possible to identify
frequent events of intolerance and create positive feed-back that lets the
patient and the attending staff interact in order to
solve them3.
The most predominant reason for
consultation was referral for treatment adherence control. ObjecÂtive data
about compliance are fundamental for making decisions during follow-up11-14;
but the clinical evaluation allowed for the identification of intolerance
events, a predictive factor for treatment withÂdrawal, even in patients who
consulted about daily data download from the device.
It has been suggested that in our
country the poor contact with the reference hospital complicates CPAP treatment
continuity21. There is low quality preliminary evidence regarding
the granting of equipment, thus the monitoring clinical work is hierarchically
organized in reference units22.
Also, other frequent clinical
problems were identified: allergic or irritable rhinitis, insomnia and bad
sleep hygiene, which motivated referrals to the respective attending
physicians, ensuring multiÂdisciplinary work3,12,13.
Published data exposed the fact
that the first 2-4 weeks after the start of treatment with positive pressure
are crucial for favoring adherence, since it is during this period that
intolerance is frequently identified3. However, we could identify
lower adherence in patients with > 1 year of CPAP (traditionÂally considered
as adapted to therapy), as described by Morrone et
al, who showed 67% compliance > 5 hours/night after 1-year follow-up in a protocolized environment15. Surprisingly, in
this series, the differences in the compliance profile could be seen after 600
nights of treatment, exposing the need to continue follow-up and analysis of
intolerance beyond the first year.
Procedures during the stages of
adaptation, titration, and monitoring of compliance and efficacy of positive
pressure require specific instruments3,14 (software management,
knowledge of different therapy devices, use of masks, knowledge of
cognitive-behavioral strategies, understanding of sleep questionÂnaires,
standardized clinical behavioral protocols, etc.), which turn the kinesiological consultation into a current discipline that
is part of those conforming the multidisciplinary team that must offer
solutions for OSA and related disorders23.
Finally, our work is
retrospective and includes the typical limitations of this type of design.
Also, attendance to this model of specific consultation depends on medical
referral, representing a bias and a limitation that complicates interpretation
and doesn’t allow the extrapolation of results to other systems of
organization.
Conclusions
Two thirds of OSA patients
evaluated in a clinical interview by physiotherapists use positive pressure more
than 4 hours per night, and half of the patients show intolerance even after
the period of adaptation.
The specialized kinesiological consultation may contribute to the
identification and resolution of difficulties, applying a protocol based on
education and training, interface selection and mid- and long-term follow-up.
Conflicts of interest: The authors
declare they have no conflict of interest with the issue related to this
original text.
This work was carried out without
funding.
References
1. Nogueira
F, Nigro C, Cambursano H, Borsini E, Silio J, Avila J.
Practical guidelines for the diagnosis and treatment of obÂstructive sleep
apnea syndrome. Medicina
(B Aires). 2013; 73(4): 349-62.
2.
Grupo Español de Sueño. Documento consenso español sobre el sÃndrome de apneas-hipopneas del sueño. Arch Bronc. 2005;41(Supl
4): 7.
3.
Nogueira JF, Borsini E, Nigro
C. Estrategias para mejorar la adaptación al tratamiento con CPAP en pacientes
con SAHOS. Rev Am Med Resp. 2016; 4: 365-77.
4. Lewis KE, Seale L, Bartle IE,
Watkins AJ, Ebden P. Early
predictors of CPAP use for the treatment of obstructive sleep apnea.
Sleep. 2004; 27(1): 134-8.
5. Budhiraja,
R, Parthasarathy S, Drake CL, et al. Early CPAP use
identifies subsequent adherence to CPAP therapy. Sleep. 2007; 30(3): 320-4.
6. Lim DC, Pack AI. Obstructive
Sleep Apnea: Update and Future. Annu Rev Med. 2017; 68: 99-112.
7. Lévy
P, Kohler M, McNicholas WT, et al. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers.
2015;1: 15015.
8. Gong F, Chen X, Wu Y, et al.
Nurse vs. physician-led care for obstructive sleep apnoea:
A systematic review and meta-analysis of randomized trials. J
Adv Nurs. 2018;
74(3): 501-6.
9. Patout
M, Arbane G, Cuvelier A,
Muir JF, Hart N, Murphy PB. Polysomnography versus limited
respiratory monitoring and nurse-led titration to optimise
non-invasive ventilation set-up: a pilot randomised
clinical trial. Thorax. 2019; 74(1): 83-6.
10. Valerio TD, Heaton K. The effects of an online educational program on nurse
practitioners’ knowledge of obstructive sleep apnea in adults. J Am Assoc Nurse Pract. 2014; 26(11):
603-11.
11. Suarez-Giron
M, Bonsignore MR, Montserrat JM. New
organisation for follow-up and assessment of
treatment efficacy in sleep apnoea. Eur Respir
Rev. 2019; 28(153).
12.
López-López L, Torres-Sánchez I, Cabrera-Martos I, OrtÃz-Rubio
A, Granados-Santiago M, Valenza MC. Nursing Interventions Improve Continuous Positive Airway Pressure
Adherence in Obstructive Sleep Apnea With Excessive Daytime Sleepiness: A
Systematic Review. Rehabil Nurs.
2020; 45(3): 140-6.
13. Sánchez-de-la-Torre M, Barbé F. Personalized medicine in sleep apnea: Towards a
new paradigm of comprehensive disease management. Med Clin (Barc). 2016;
147(10): 444-6.
14. Shelgikar
AV, Durmer JS, Joynt KE,
Olson EJ, Riney H, Valentine P. Multidisciplinary
sleep centers: strategies to improve care of sleep disorders patients. J Clin Sleep Med. 2014; 10(6): 693-7.
15.
Morrone E, Giordano A, Carli
S, et al. Something is changing in adherence to CPAP therapy:
real world data after 1 year of treatment in patients with obstructive sleep
apnea. Eur Respir J. 2020;
55(3): 1901419.
16.
Nogueira F, De Luca M, Simonelli G, Vera D, Vera S, Rey
R. ¿Qué pasa con los pacientes luego de que se les diagnostica Apneas del
Sueño? Rev Am Med Resp. 2007; 2: 41-7.
17.
Décima T, Maldonado L, Bosio M, et al. Cumplimiento y
abandono de CPAP en pacientes con sÃndrome de apneas del sueño. Rev Am Med Resp. 2013; 4: 197-206.
18. Nogueira
JF, Simonelli G, Giovini V,
et al. Access to CPAP treatment in patients with moderate to severe sleep apnea
in a Latin American City. Sleep Sci. 2018; 11(3): 174-82.
19. Wolkove
N, Baltzan M, Kamel H, et
al. Long-term compliance with continuous positive airway pressure in patients
with obstructive sleep apnea. Can Respir J. 2008; 15:
365-9.
20. Wang Y, Gao
W, Sun M, et al. Adherence to CPAP in patients with obstructive sleep apnea in
a Chinese population. Respir Care. 2012;
57: 238-43.
21.
Leiva Agüero S, Larrateguy LD, Nogueira F, et al.
Tratamiento con presión positiva de la Apnea Obstructiva del Sueño. Posición de
la Asociación Argentina de Medicina Respiratoria. Rev
Am Med Resp 2019; 4:
332-48.
22.
Nogueira JF, Giovini V, Borsini
E, et al. Evaluación de la calidad de servicio prestado a pacientes con apneas
del sueño por parte de diferentes proveedores de CPAP. Abstract
43º Congreso Argentino de Medicina Respiratoria. Rev
Am Med Resp. 2015; Supl 1-89.
23.
Borsini E, Décima T. ¿Cómo debemos organizar el
seguimiento de los pacientes con sÃndrome de apneas-hipopneas
durante el sueño? Rev Am Med
Resp. 2014; 2: 187-9.