Comparison of Active Cycle of Breathing Technique and Pursed Lip Breathing With TheraPep
Condition: Chronic Obstructive Pulmonary Disease Exacerbation
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Disease Progression
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Thera PEP; ACBT and PLB
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 ten PEP breaths, the patient will have the mouthpiece removed and be instructed to do two or three "puff" coughs. When secretions need to be brought up, a good cough will do the trick. During the duration of the treatment, which will last around thirty minutes, the patient will be asked to complete three cycles of ten breaths each.; On the day of the ACBT, the patient will be taught to place dental cotton swabs between the cheek and gum, as well as beneath the tongue, to absorb saliva and prevent contamination of the collected sputum by saliva. Throughout the treatment, the patient will be urged to maintain a comfortable sitting position. The patient will then be instructed to perform PLB at a normal tidal volume (for approximately 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 a huff cough, followed by a medium breath in and a huff cough again. Approximately thirty minutes will pass over the course of this session.
Other intervention name(s): ACBT and PLB
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic obstructive pulmonary disease; pursed lip breathing; active cycle breathing technique; airway clearance technique