Bronchiolitis
Conditions
Keywords
bronchiolitis, Wang score, Sa02, airway clearance techniques, intrapulmonary percussive ventilation, assisted autogenic drainage
Brief summary
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.
Interventions
OTHERinhalation 4ml hypertonic saline 3% 3x/day
PROCEDUREAssisted Autogenic Drainage
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 24 Months
Healthy volunteers
No
Inclusion criteria
* first period of wheezing * Wang score between 3 and 7 * age \< 24 months * Sa02\> 90%
Exclusion criteria
* ICU patients * mechanical ventilation * use of antibiotics * use of corticosteroids * gestational age \< 34 weeks * chronic cardiac or pulmonary disease * no parental consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 6 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wang Score | before treatment, immediately after treatment and 1h after treatment | — |
| Heartrate | before, after and 1h after intervention | — |
| Oxygen Saturation (SaO2) | before, after and 1h after treatment | oxygen saturation (SaO2) measured by pulse -oximetry |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intrapulmonary Percussive Ventilation 20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day | 31 |
| Assisted Autogenic Drainage 20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day | 31 |
| Control 20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day | 31 |
| Total | 93 |
Baseline characteristics
| Characteristic | Intrapulmonary Percussive Ventilation | Assisted Autogenic Drainage | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 31 Participants | 31 Participants | 31 Participants | 93 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Belgium | 31 participants | 31 participants | 31 participants | 93 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 18 Participants | 49 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 13 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 34 | 0 / 36 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 | 0 / 36 |
Outcome results
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)
Time frame: 6 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intrapulmonary Percussive Ventilation | Length of Hospital Stay | 3.5 days | Standard Deviation 1.3 |
| Assisted Autogenic Drainage | Length of Hospital Stay | 3.6 days | Standard Deviation 1.4 |
| Control | Length of Hospital Stay | 4.5 days | Standard Deviation 1.9 |
Secondary
Heartrate
Time frame: before, after and 1h after intervention
Secondary
Oxygen Saturation (SaO2)
oxygen saturation (SaO2) measured by pulse -oximetry
Time frame: before, after and 1h after treatment
Secondary
Wang Score
Time frame: before treatment, immediately after treatment and 1h after treatment