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Effectiveness Of Modified Chest PT Technidue In Pre And Post-Operative Program In Patients Open Heart Surgery

13 ottobre 2016 aggiornato da: Mrs.atidtaya yotwong, Khon Kaen University

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

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Atidtaya yotwong, master
  • Numero di telefono: +66945423887
  • Email: amaon21@gmail.com

Backup dei contatti dello studio

Luoghi di studio

    • KhonKaen
      • Maung Khon Kaen, KhonKaen, Tailandia, 40000
        • Reclutamento
        • Khon Kaen Hospital
        • Contatto:
          • Atidtaya Yotwong, Master
          • Numero di telefono: 1322 +66043336789
          • Email: amaon21@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients with a leaky septal defect, valvular heart disease and coronary artery disease, both male, and female, scheduled for primary elective open heart surgery age 20-80 years who had the ability to communicate and understand informed consent.

Exclusion Criteria:

  • Unstable angina pectoris at the moment of selection or during the program
  • Complex ventricular and uncontrolled arrhythmia
  • Uncontrolled high blood pressure (> 140/90 mm/Hg)
  • A history of cerebrovascular accident
  • Presence of a neuromuscular disorder
  • Cardiovascular instability or the existence an aneurysm
  • Ejection fractions were less than 0.40
  • Unable to participate because of physical limitations

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Modify group
For 2 days pre-surgery and continuous post-surgery repeated for 5 sets a day. The patients in Modify group will be taught 4 modify techniques and receive cardiac rehabilitation phase 1 in postoperative period.

Modify chest physical therapy

  • oscillated incentive spirometry (OIS) with inspiratory load of 5-8 cm H2O 30 times/set
  • oscillated positive expiratory pressure (OPEP) with expiratory load of 5-8 cm H2O 30 times/set
  • Coughing with splinting 3 times/set
  • Chest mobilization with overhead both arms rises 10 times/set total 5 set/day
Comparatore fittizio: Conventional group
For 2 days pre-surgery and continuous post-surgery repeated for 5 sets a day. The patients in Modify group will be taught 3 conventional techniques and receive cardiac rehabilitation phase 1 in postoperative period.

Routine chest physical therapy

  • Deep breathing exercise (upper and lower costal and diaphragmatic breathing exercise) as deep as possible for 10 times/set/level
  • Coughing with splinting 3 times/set
  • Chest mobilization with overhead both arms raised 10 times/set total 5 set/day

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of PPCs,
Lasso di tempo: postoperative day 1-5
Incidence of PPCs were recorded from atelectasis, pneumonia, and pleural effusion according to clinical (symptoms and examinations) and radiological criteria in postoperative day 1-5 and diagnosed by the physician.
postoperative day 1-5
The duration of breathing with a mode of mechanical ventilator and duration of intubation time
Lasso di tempo: postoperative 4 weeks
Duration of mode of mechanical ventilation and intubation times. Dependent variables, mode and duration of mechanical ventilation, starting records mode of mechanical ventilator when the patients arrive to ICU until extubation
postoperative 4 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
length of ICU and hospital stay
Lasso di tempo: postoperative 4 weeks

Length of ICU stay starting record when the patients arrive to ICU until move out.

Length of hospital stay were record in postoperative period until discharge.

postoperative 4 weeks
Pulmonary function test
Lasso di tempo: pre-operation and post-operative 1-5 days

Pulmonary function test were monitored before starting the training, after training 1 day before surgery and 5 days postoperative surgery. Slow vital capacity (SVC), Inspiratory capacity (IC) and Forced expiratory flow (FEF) measured by spirometer (Spirometer MicroLab ML3500) 3 times and records the best value. Then, the SVC and IC has been calculated by a computer program to find value of slow vital capacity %predict (SVC %predict) and inspiratory capacity (IC %predict).

Tidal volume (VT) was monitor before and after training every in pre-operation and post-operative 1-5 days, measured by wright respirometer

pre-operation and post-operative 1-5 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Atidtaya yotwong, master, Khon Kaen University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2016

Completamento primario (Anticipato)

1 aprile 2017

Completamento dello studio (Anticipato)

1 aprile 2017

Date di iscrizione allo studio

Primo inviato

15 agosto 2016

Primo inviato che soddisfa i criteri di controllo qualità

5 settembre 2016

Primo Inserito (Stima)

9 settembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 ottobre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 ottobre 2016

Ultimo verificato

1 ottobre 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Effect of modify chest PT

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .