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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02645695
Other study ID # erzincan university
Secondary ID
Status Completed
Phase N/A
First received December 30, 2015
Last updated January 1, 2016
Start date February 2014
Est. completion date August 2014

Study information

Verified date January 2016
Source Erzincan University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

Effects of the high frequent chest wall oscillation technique applied on the patients who were intubated in intensive care unit were investigated.

A total of 30 patients who were intubated and under the mechanical ventilator supplied, were included in the study. While the control group (n=15) received routine pulmonary rehabilitation technique, the study group (n=15) was administered high frequency chest wall oscillation for 72 hours as 4 times of 15-minute intervals, in addition to the pulmonary rehabilitation technique. Patients 'APACHE-II scores, dry sputum weight, Lung Collapse Index and blood gas values were measured at the hours 24th, 48th and 72nd, and endotracheal aspirate culture was studied at initial and 72nd. In addition, patient outcomes were evaluated at the end of the first week.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- aged over 18 years

- Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital

Exclusion Criteria:

- Patients with rib fracture

- acute hemorrhage

- unstable intracranial pressure

- existence of chest drainage tube and those have history of spinal surgery,

- skin infection in the back and chest area and subcutaneous emphysema

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
routine pulmonary rehabilitation
received routine pulmonary rehabilitation consisted of position giving technique (left lateral, supine, right lateral), chest wall percussion, postural drainage and airway aspiration at every 3 hours.
chest wall vibration technique
administered chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours. Chest vibration method was applied with 7-10 hz frequency given by a ped wrapped around the thorax and pulmonary rehabilitation with 3 mmHg pressure four times a day with 15-minute periods (TheVest® Model 205).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
ILKE KUPELI

References & Publications (11)

Chen YC, Wu LF, Mu PF, Lin LH, Chou SS, Shie HG. Using chest vibration nursing intervention to improve expectoration of airway secretions and prevent lung collapse in ventilated ICU patients: a randomized controlled trial. J Chin Med Assoc. 2009 Jun;72(6) — View Citation

Ciesla ND. Chest physical therapy for patients in the intensive care unit. Phys Ther. 1996 Jun;76(6):609-25. Review. — View Citation

Esguerra-Gonzalez A, Ilagan-Honorio M, Fraschilla S, Kehoe P, Lee AJ, Marcarian T, Mayol-Ngo K, Miller PS, Onga J, Rodman B, Ross D, Sommer S, Takayanagi S, Toyama J, Villamor F, Weigt SS, Gawlinski A. CNE article: pain after lung transplant: high-frequency chest wall oscillation vs chest physiotherapy. Am J Crit Care. 2013 Mar;22(2):115-24. doi: 10.4037/ajcc2013869. — View Citation

Gross D, Zidulka A, O'Brien C, Wight D, Fraser R, Rosenthal L, King M. Peripheral mucociliary clearance with high-frequency chest wall compression. J Appl Physiol (1985). 1985 Apr;58(4):1157-63. — View Citation

Hansen LG, Warwick WJ, Hansen KL. Mucus transport mechanisms in relation to the effect of high frequency chest compression (HFCC) on mucus clearance. Pediatr Pulmonol. 1994 Feb;17(2):113-8. Review. — View Citation

Langenderfer B. Alternatives to percussion and postural drainage. A review of mucus clearance therapies: percussion and postural drainage, autogenic drainage, positive expiratory pressure, flutter valve, intrapulmonary percussive ventilation, and high-fre — View Citation

Manzano RM, Carvalho CR, Saraiva-Romanholo BM, Vieira JE. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial. Sao Paulo Med J. 2008 Sep;126(5):269-73. — View Citation

Massard G, Wihlm JM. Postoperative atelectasis. Chest Surg Clin N Am. 1998 Aug;8(3):503-28, viii. Review. — View Citation

Ntoumenopoulos G, Presneill JJ, McElholum M, Cade JF. Chest physiotherapy for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2002 Jul;28(7):850-6. Epub 2002 May 24. — View Citation

Oermann CM, Swank PR, Sockrider MM. Validation of an instrument measuring patient satisfaction with chest physiotherapy techniques in cystic fibrosis. Chest. 2000 Jul;118(1):92-7. — View Citation

Warwick WJ, Wielinski CL, Hansen LG. Comparison of expectorated sputum after manual chest physical therapy and high-frequency chest compression. Biomed Instrum Technol. 2004 Nov-Dec;38(6):470-5. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline of Lung Collapse Index (LCI) values were recorded by listening both the lungs and scoring between 0 and 4 (0: normal expansion, 1: single lobe collapse, 2: 2 lobe collapse, 3: multiple lobe collapse) at six month six month Yes
Secondary weight of the dry sputum after six month six month Yes
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