NCT02645695

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

December 30, 2015

Last Update Submit

January 1, 2016

Conditions

Atelectasis

Keywords

Pulmonary RehabilitationChest PhysiotherapyHigh Frequency Chest Wall Oscillation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • weight of the dry sputum after six month

    six month

Study Arms (2)

routine pulmonary rehabilitation

ACTIVE COMPARATOR

routine pulmonary rehabilitation consisted of position giving technique

Device: routine pulmonary rehabilitationDevice: chest wall vibration technique

chest wall vibration technique

ACTIVE COMPARATOR

chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours.

Device: routine pulmonary rehabilitationDevice: chest wall vibration technique

Interventions

routine pulmonary rehabilitationDEVICE

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 techniqueroutine pulmonary rehabilitation
chest wall vibration techniqueDEVICE

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).

chest wall vibration techniqueroutine pulmonary rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged over 18 years
  • Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 23455861BACKGROUND

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

    PMID: 9742334BACKGROUND

  • 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. doi: 10.1590/s1516-31802008000500005.

    PMID: 19099160BACKGROUND

  • 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. doi: 10.1007/s00134-002-1342-2. Epub 2002 May 24.

    PMID: 12122521RESULT

  • Ciesla ND. Chest physical therapy for patients in the intensive care unit. Phys Ther. 1996 Jun;76(6):609-25. doi: 10.1093/ptj/76.6.609.

    PMID: 8650276RESULT

  • 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. doi: 10.1378/chest.118.1.92.

    PMID: 10893365RESULT

  • 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. doi: 10.2345/0899-8205(2004)38[470:COESAM]2.0.CO;2.

    PMID: 15635998RESULT

  • 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. doi: 10.1002/ppul.1950170207.

    PMID: 8165037RESULT

  • 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. doi: 10.1152/jappl.1985.58.4.1157.

    PMID: 3988672RESULT

  • 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-frequency chest compression with the ThAIRapy Vest. J Cardiopulm Rehabil. 1998 Jul-Aug;18(4):283-9. doi: 10.1097/00008483-199807000-00005.

    PMID: 9702607RESULT

  • 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):316-22. doi: 10.1016/S1726-4901(09)70378-8.

    PMID: 19541567RESULT

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
head of Anesthesiology and Reanimation

Study Record Dates

First Submitted

December 30, 2015

First Posted

January 5, 2016

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

January 5, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share