Pulmonary Complications Clinical Trial
Official title:
Effectiveness of Modified Chest Physical Therapy Techniques Using New Device in Pre and Post-operative Program in Patients Undergoing Open Heart Surgery.
The purpose of this study is to explore effectiveness of modified chest physical therapy techniques using new device in pre and post-operative program in patients undergoing open heart surgery
Postoperative pulmonary complications, PPCs are common after open heart surgery. The causes
of PPCs is complex and involve numerous factors in cardiac surgery including general
anesthesia, cardiopulmonary bypass technique, median sternotomy, internal mammary artery
dissection, topical cooling for myocardial protection, process of surgery, pulmonary risk
factor of patients preoperative and on intubation. These factors could lead to pain and
change in breathing pattern and induced respiratory muscle dysfunction. Causes of
restriction lung volume, reduced lung volume, impaired airway clearance and secretion
accumulation lead to poor ventilation and gas exchange. These are major contributing factors
of PPCs e.g. atelectasis and pneumonia, which increase the load on cardiac function. The
cardio-respiratory dysfunction could result in prolonged intubation and mechanical
ventilator dependence in ICU and are an important cause of morbidity and mortality. Also,
PPCs increase use of medical resources, extend the length of hospital stays and increase
hospital costs .
The reducing of PPCs need the chest physical therapy (CPT) to solve this problem. The goals
of CPT are to increase lung volume, improve airway secretion clearance, and improve physical
ambulation and movement. The CPT techniques are composed of deep breathing exercise,
coughing and huffing, force expiratory technique, percussion and vibration, and early
mobilization and change of position. However, these complications were still available and
high incidence. May be, because CPT techniques are urged pain, not to clear secretion, the
patients has not enough time to performed the CPT techniques in preoperative period and the
atelectasis occurred immediately after surgery. But CPT in patients after cardiac surgery is
mostly training after extubation. So, CPT have develops new technique or breathing device
for increase lung volume and improve airway secretion clearance without increasing pain to
reduce the incidence of PPCs.
Incentive spirometry (IS) device is a widely used for the prophylaxis and treatment of
respiratory complications in postsurgical patients. The previous study suggested that IS
training could reduce an incidence of PPCs. However, several publications have
controversisce results the effectiveness of IS when compared other chest physical therapy in
preventing PPCs in patients undergoing cardiac surgery. Recent studies suggested that in
patients undergoing cardiac surgery no evidence of benefit from IS to prevent PPCs,
improving pulmonary function and oxygenation and reducing the length of a hospital when
compared with preoperative education or standard postsurgical physical therapy. The
comparison the effectiveness between IS and conventional postoperative chest physical
therapy showed that did not difference. This may be caused by IS device in there studied not
enough increase lung volume especially lower lung, this is often found atelectasis.
Moreover, this device has not a property of airway clearance, which the secretion
accumulation is a primary cause of PPCs.
Positive expiratory pressure (PEP) device was popular used in patients after cardiac surgery
practically and demonstrated to reduce the incidence of PPCs. Due to, the PEP technique can
prevent the closure of the trachea during exhalation, resulting the increase of lung volumes
and the mobilization of secretions. Earlier study had compared the effect of different deep
breathing exercise, on PPCs after CABG surgery. However, in such studies there studies to
immediate effects of 30 deep breaths performed with or without a mechanical device on
atelectasis after 2 days surgery, and did not perform adequate follow-up. A resulting lack
of evidence indicating that PEP technique in clinical practice, the patients undergoing
cardiac surgery. Due to, in routine treatment, the breathing exercise is repeated every
daytime and for several days. It is not unlikely that repeated practice will have a more
substantial effect. Moreover, Westerdahl et al. (2003) found that the aerated lung area was
increase in the IS+PEP group, when compared to the PEP with deep breathe group. This data is
an interesting point that, if the patients practice breathing exercise with IS+PEP at 30
breathes every daytime and several days maybe the difference between patients practice
IS+PEP and chest physical therapy on the incidence of PPCs in patients cardiac surgery.
The study of the effect of IS+PEP on reducing the incidence of PPCs compared to respiratory
physiotherapy intervention in patients undergoing cardiac surgery was a few studied.
Westerdahl et al. (2001) studied on the effectiveness of three deep breathing techniques in
male patients after CABG surgery and the results found that the occurrence of atelectasis
was no statistical difference between IS+PEP group, compared to deep breath and PEP group.
This result is contrastly to the results of Haeffener et al., (2008). In patients undergoing
CABG surgery, combinated treatment with IS and EPAP helped to reduction the PPCs
significantly. However, the studied has a limitation of methodology due to the patients are
not comprehensive.
Thus, this study was interested in the effects of practicing IS combine PEP to reduce the
incidence of PPCs, especially atelectasis in patients undergoing cardiac surgery by
BreatheMAX® v.2. Due to, BreatheMAX has been developed and manufactured in Thailand,
breathing device has multiple functions with cheaper price and easy. Moreover, IS of
BreatheMAX has a humidified and vibrate mechanisms during inhaling, thus it can reduce the
viscosity of secretion and increases the ability to remove secretions without causing a dry
mouth. The obstruction of secretions is the primary cause of atelectasis in patients
undergoing cardiac surgery. But other devices are manufacture in abroad and single function,
make time to use several functions need for multiple devices.
In order to prevent PPCs, the patients have to be well trained all the CPT techniques used
in postoperative period with a physiotherapist. However, in clinical practice patients are
always admitted hospital just 1-2 days before the operation, and there is not enough time to
practice the CPT techniques. In addition, the taught of CPT techniques may be challenging
and redundant to practice in short time. To solve this problem, the illustrated CPT
techniques have to be selected and directed toward airway clearance, and alveolar
recruitment effects also need to be fewer and efficient techniques feasible to do easily by
the post-operative patients. Consequently, apart from huffing or coughing, using the proper
breathing device would be easier and enjoy the way of practice and acceptable by the
vulnerable patients during pre-operative period. IS and PEP techniques will be selected
because of their therapeutic effects. However, there is no evidence supporting the
effectiveness of the IS and PEP techniques in pre-operative and continue in post-operative
period in order to prevent PPCs. The hypothesized scope that if the patients can learn and
do the techniques well, at before and after operative period, the PPCs can reduced or
prevented which could result to prevent or reduce the incidence of PPCs. Therefore, this
study aimed to evaluate the effectiveness of preoperative physical therapy program
(Oscillated PEP + Oscillated IS) on the PPCs in patients who underwent cardiac surgery.
In conclusion, this research proposal has to study the effectiveness of Oscillated PEP and
Oscillated IS (OPEP+OIS) techniques compare deep breathing exercise conduct pre-operative
and continue post-operative period on the incidence of PPCs, especially atelectasis, the
length of a mechanical ventilator, the length of intubation, and length of ICU and hospital
stay.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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