Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05691387 |
Other study ID # |
REC-44/06/445 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 30, 2022 |
Est. completion date |
May 15, 2023 |
Study information
Verified date |
May 2023 |
Source |
University of Jazan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to investigate the short-term effects of two different breathing
techniques (the active cycle breathing technique (ACBT) and the pursed lip breathing
technique (PLB)) with Thera PEP® on the clearance of secretions and the oxygen saturation of
individuals who have recently experienced an acute exacerbation of chronic obstructive
pulmonary disease (COPD) in individuals who have recently experienced an acute exacerbation
of COPD (COPD). Thirty patients will each have an acute COPD exacerbation seen on them, and
then they will be randomly allocated to one of two groups (1. ACBT and PLB; 2. Thera PEP).
Participants in a study employing a design known as a within-subject randomized crossover
will be given the instruction to carry out each procedure on consecutive days as part of the
study. In this study, the dependent variables will include blood pressure, heart rate, oxygen
saturation (SpO2), respiratory rate, peak expiratory flow rate (PEFR), visual analog scale
(VAS), sputum volume, and the breathlessness, cough, and sputum scale. In addition, the
independent variables will include sputum volume (BCSC). The patient's desired course of
treatment will also be taken into account. These dependent variables will be examined at
three distinct moments in time: at the beginning of the study (the baseline), immediately
after treatment, and thirty minutes after treatment has been completed.
Description:
Methods:
There will be a total of thirty COPD patients recruited. Because of the rapid progression of
their chronic obstructive pulmonary disease, these patients are going to need to be
hospitalized. An acute exacerbation of COPD is suspected when there is an upper respiratory
tract infection, a high temperature for no apparent reason, an increase in wheezing and
coughing, or a rise in respiratory rate or heart rate above baseline. All of these symptoms
are considered to be indications of an acute exacerbation of COPD. Co-morbidities, including
but not limited to angina, indication for ventillatory support, neurological deficits, severe
hemodynamic instability (including but not limited to cor pulmonale, cardiac arrhythmias,
pulmonary embolism, pneumothorax, congestive heart failure, and GOLD stage IV: very severe
COPD), and indication for ventilatory support will be used as exclusion criteria.
Interventions:
Individuals who will satisfy the inclusion and exclusion criteria will be given information
regarding the two treatments (ACBT+PLB and PEP therapy to be offered by Thera PEP), and then
they will be randomly randomized to either group (A or B) (A or B). Group A patients will get
ACBT+PLB on day one of treatment, followed by PEP therapy using Thera PEP on day two.
Treatment for patients in Group B will begin with PEP on Day 1, followed by ACBT+PLB on Day
2.
Sitting comfortably, patients receiving Thera PEP will be told to place dental cotton swabs
between their cheek and gum, and then under their tongue, to absorb saliva and prevent
contamination of the collected sputum by the patient's own saliva. The diameter of the
opening will be modified to achieve a ventilation rate of 1:4. The patient will be taught to
take in a larger than normal breath but not fill the lungs to capacity in order to maintain a
tight seal during exhalation. After completing 10 PEP breaths, the patient will have the
mouthpiece removed and be instructed to produce 2-3 "huff" coughs. When secretions need to be
brought up, a good cough will do the trick. The patient will be instructed to do three sets
of ten breaths each during the length of the therapy, which will last roughly thirty minutes
in total. On the day of the ACBT, the patient will be instructed to place dental cotton swabs
between the cheek and gum, as well as beneath the tongue, in order to absorb saliva and avoid
the collected sputum from being tainted by the patient's own saliva. We'll want the patient
to settle in for the duration of the procedure. After that, the patient will be given
instructions to perform PLB at a normal tidal volume (for about 6 breaths), followed by 3-4
deep inspirations with relaxed exhalation (thoracic expansion exercise), and finally, another
period of breathing control, i.e., PLB, followed by FET, i.e., a deep breath in and to do
huff cough, followed by a medium breath in and again a huff cough. About thirty minutes will
be spent in this procedure.
Outcome:
On day 0 (when no intervention is given), day 1 (at bedtime), and day 2, patients will be
asked to fill out the sputum breathlessness cough scale (one of the dependent variables) (at
bedtime). Besides the basics like pulse, blood pressure, and respiration rate, we'll also
have a look at things like arterial oxygen saturation (SpO2), peak expiratory flow rate
(PEFR), visual analog scale (VAS), and sputum volume to get a full picture of the patient's
health (SV). Patients in both groups will be polled on which therapy modality they like best
on Day 3.
Statistical analyses:
Data will be analyzed using SPSS for Windows, version 26. Treatment effects on the dependent
variables will be analyzed using repeated-measures analysis of variance (ANOVA), with time as
the within-subject component and the three measurements (baseline, posttest, and 30 minutes
posttest) as the independent variables. Repeated-measures analysis will be used to examine
correlations between participants, and a crossover layout will be used for variables that
show statistical significance. The statistical study of the interaction between the period
effect, the treatment period effect, and the treatment effect will be conducted using the
independent-sample T-test. For the purposes of this research, a p value of 0.05 will be
considered significant.