AtelectasisNCT02645695
What is the Effective Pulmonary Physiotherapy Method in Critically Care Patients?
A study testing routine pulmonary rehabilitation and chest wall vibration technique in people with Atelectasis, run by ILKE KUPELI.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis
- What is being tested?
- routine pulmonary rehabilitation and chest wall vibration technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged over 18 years
- Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital
Who cannot join
- 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
About this study
Official title: Can High Frequency Chest Wall Oscillation Accelerate the Discharged of Intubated Intensive Care Patients?
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.
- Conditions
- Atelectasis
- Being tested
- routine pulmonary rehabilitation, chest wall vibration technique
- Keywords
- Pulmonary Rehabilitation, Chest Physiotherapy, High Frequency Chest Wall Oscillation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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).
| Study group | Role | What they receive |
|---|---|---|
| routine pulmonary rehabilitation | Active comparator | routine pulmonary rehabilitation consisted of position giving technique Receives: Device: routine pulmonary rehabilitation; Device: 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. Receives: Device: routine pulmonary rehabilitation; Device: chest wall vibration technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six month
Secondary outcomes (1)
weight of the dry sputum after six month
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ILKE KUPELI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ILKE KUPELI, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645695
- Sponsor's protocol ID
- erzincan university
- Status last verified
- Jan 2016
- First submitted
- 30 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23455861Massard G, Wihlm JM. Postoperative atelectasis. Chest Surg Clin N Am. 1998 Aug;8(3):503-28, viii.
PubMed 9742334Manzano 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.
PubMed 19099160Ntoumenopoulos 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.
PubMed 12122521Ciesla 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.
PubMed 8650276Oermann 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.
PubMed 10893365Warwick 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.
PubMed 15635998Hansen 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.
PubMed 8165037Gross 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.
PubMed 3988672Langenderfer 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.
PubMed 9702607Chen 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.
PubMed 19541567
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can High Frequency Chest Wall Oscillation Accelerate the Discharged of Intubated Intensive Care Patients?
- ClinicalTrials.gov ID
- NCT02645695
- Acronym / sponsor ID
- erzincan university
- Conditions
- Atelectasis
- Keywords
- Pulmonary Rehabilitation, Chest Physiotherapy, High Frequency Chest Wall Oscillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ILKE KUPELIUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine pulmonary rehabilitation | Active comparator | Device: routine pulmonary rehabilitation, Device: chest wall vibration techniqueroutine pulmonary rehabilitation consisted of position giving technique |
| chest wall vibration technique | Active comparator | Device: routine pulmonary rehabilitation, Device: chest wall vibration techniquechest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged over 18 years
- Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine pulmonary rehabilitationreceived 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. | Device | chest wall vibration technique, routine pulmonary rehabilitation |
| chest wall vibration techniqueadministered 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). | Device | chest wall vibration technique, routine pulmonary rehabilitation |
Primary outcome
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
Time frame: six month
1 secondary outcome
weight of the dry sputum after six month
Time frame: six month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 23455861Esguerra-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.
- Background: PubMed 9742334Massard G, Wihlm JM. Postoperative atelectasis. Chest Surg Clin N Am. 1998 Aug;8(3):503-28, viii.
- Background: PubMed 19099160Manzano 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.
- Results publication: PubMed 12122521Ntoumenopoulos 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.
- Results publication: PubMed 8650276Ciesla 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.
- Results publication: PubMed 10893365Oermann 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.
- Results publication: PubMed 15635998Warwick 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.
- Results publication: PubMed 8165037Hansen 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.
- Results publication: PubMed 3988672Gross 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.
- Results publication: PubMed 9702607Langenderfer 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.
- Results publication: PubMed 19541567Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing routine pulmonary rehabilitation and chest wall vibration technique in people with Atelectasis, run by ILKE KUPELI.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645695, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.