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The purpose of this study is to investigate the effectiveness of two airway clearance techniques; Intrapulmonary Percussive Ventilation and Assisted Autogenic Drainage in hospitalized infants under the age of 2 with acute viral bronchiolitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrapulmonary Percussive Ventilation | Experimental | 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day |
|
| Assisted Autogenic Drainage | Active Comparator | 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day |
|
| control | No Intervention | 20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhalation 4ml hypertonic saline 3% 3x/day | Other |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2) | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wang Score | before treatment, immediately after treatment and 1h after treatment | |
| Heartrate | before, after and 1h after intervention | |
| Oxygen Saturation (SaO2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uz Brussel | Jette | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37010196 | Derived | Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrapulmonary Percussive Ventilation | 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Intrapulmonary Percussive Ventilation |
| FG001 | Assisted Autogenic Drainage |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Intrapulmonary Percussive Ventilation |
| Device |
|
| Assisted Autogenic Drainage | Procedure |
|
oxygen saturation (SaO2) measured by pulse -oximetry |
| before, after and 1h after treatment |
20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Assisted Autogenic Drainage |
| FG002 | Control | 20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrapulmonary Percussive Ventilation | 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day |
| BG001 | Assisted Autogenic Drainage | 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day |
| BG002 | Control | 20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Hospital Stay | Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2) | Posted | Mean | Standard Deviation | days | 6 days |
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| Secondary | Wang Score | Not Posted | before treatment, immediately after treatment and 1h after treatment | |||||||||||||||||||||||||||||||||||||||
| Secondary | Heartrate | Not Posted | before, after and 1h after intervention | |||||||||||||||||||||||||||||||||||||||
| Secondary | Oxygen Saturation (SaO2) | oxygen saturation (SaO2) measured by pulse -oximetry | Not Posted | before, after and 1h after treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrapulmonary Percussive Ventilation | 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Intrapulmonary Percussive Ventilation | 0 | 33 | 0 | 33 | ||
| EG001 | Assisted Autogenic Drainage | 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day inhalation 4ml hypertonic saline 3% 3x/day Assisted Autogenic Drainage | 0 | 34 | 0 | 34 | ||
| EG002 | Control | 20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day | 0 | 36 | 0 | 36 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Filip Van Ginderdeuren | Vrije Universiteit Brussel | +3224763916 | filip.vanginderdeuren@uzbrussel.be |
| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|