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Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial.

ABSTRACT: Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis.We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n=246) or nasal suction (NS, control group, n=250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97-2.73) for the control group and 2.02 days (95% CI 1.96-2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]=1.09, 95% CI 0.91-1.31, p=0.33). No treatment by age interaction was found (p=0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]=10.2, 95% CI 1.3-78.8, p=0.005 and RR=5.4, 95% CI 1.6-18.4, p=0.002, respectively). No difference between groups in bradycardia with or without desaturation (RR=1.0, 95% CI 0.2-5.0, p=1.00 and RR=3.6, 95% CI 0.7-16.9, p=0.10, respectively) was found during the procedure. Parents reported that the procedure was more arduous in the group treated with IET (mean difference=0.88, 95% CI 0.33-1.44, p=0.002), whereas there was no difference regarding the assessment of the child's comfort between both groups (mean difference=-0.07, 95% CI -0.53 to 0.38, p=0.40). No evidence of differences between groups in intensive care admission (RR=0.7, 95% CI 0.3-1.8, p=0.62), ventilatory support (RR=2.5, 95% CI 0.5-13.0, p=0.29), and antibiotic treatment (RR=1.0, 95% CI 0.7-1.3, p=1.00) was observed.IET + AC had no significant effect on time to recovery in this group of hospitalized infants with bronchiolitis. Additional studies are required to explore the effect of chest physiotherapy on ambulatory populations and for infants without a history of atopy.ClinicalTrials.gov NCT00125450.

SUBMITTER: Gajdos V

PROVIDER: S-EPMC2946956 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial.

Gajdos Vincent V Katsahian Sandrine S Beydon Nicole N Abadie Véronique V de Pontual Loïc L Larrar Sophie S Epaud Ralph R Chevallier Bertrand B Bailleux Sylvain S Mollet-Boudjemline Alix A Bouyer Jean J Chevret Sylvie S Labrune Philippe P

PLoS medicine 20100928 9

<h4>Background</h4>Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis.<h4>Methods and findings< ...[more]

PMID: 20927359

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Project description:BACKGROUND: Bronchiolitis is a major health burden in infants globally, particularly among Indigenous populations. It is unknown if 3?weeks of azithromycin improve clinical outcomes beyond the hospitalization period. In an international, double-blind randomized controlled trial, we determined if 3?weeks of azithromycin improved clinical outcomes in Indigenous infants hospitalized with bronchiolitis. METHODS: Infants aged ?24?months were enrolled from three centers and randomized to receive three once-weekly doses of either azithromycin (30?mg/kg) or placebo. Nasopharyngeal swabs were collected at baseline and 48?h later. Primary endpoints were hospital length of stay (LOS) and duration of oxygen supplementation monitored every 12?h until judged ready for discharge. Secondary outcomes were: day-21 symptom/signs, respiratory rehospitalizations within 6?months post-discharge and impact upon nasopharyngeal bacteria and virus shedding at 48?h. RESULTS: Two hundred nineteen infants were randomized (n?=?106 azithromycin, n?=?113 placebo). No significant between-group differences were found for LOS (median 54?h for each group, difference?=?0?h, 95% CI: -6, 8; p?=?0.8), time receiving oxygen (azithromycin?=?40?h, placebo?=?35?h, group difference?=?5?h, 95% CI: -8, 11; p?=?0.7), day-21 symptom/signs, or rehospitalization within 6?months (azithromycin n?=?31, placebo n?=?25 infants, p?=?0.2). Azithromycin reduced nasopharyngeal bacterial carriage (between-group difference 0.4 bacteria/child, 95% CI: 0.2, 0.6; p?<?0.001), but had no significant effect upon virus detection rates. CONCLUSION: Despite reducing nasopharyngeal bacterial carriage, three large once-weekly doses of azithromycin did not confer any benefit over placebo during the bronchiolitis illness or 6?months post hospitalization. Azithromycin should not be used routinely to treat infants hospitalized with bronchiolitis. CLINICAL TRIAL REGISTRATION: The trial was registered with the Australian and New Zealand Clinical Trials Register: Clinical trials number: ACTRN1261000036099.

Project description:ImportancePulse oximetry is a noninvasive technology that is integral to the supportive care of hospitalized infants with bronchiolitis. A multicenter, randomized trial comparing the effectiveness of intermittent vs continuous pulse oximetry found similar length of hospital stay and safety outcomes, and greater nursing satisfaction, with intermittent monitoring.ObjectivesTo evaluate the cost-effectiveness of intermittent vs continuous pulse oximetry in hospitalized infants with stabilized bronchiolitis.Design, setting, and participantsAn economic evaluation concurrent with a randomized trial in community and tertiary children's hospitals in Ontario, Canada, was conducted using a probabilistic analysis. Patients were enrolled from November 1, 2016, to May 31, 2019. Data included infants aged 4 weeks to 24 months hospitalized with bronchiolitis, with or without supplemental oxygen, after stabilization. The cost-effectiveness analysis adopted a societal and health care system perspective and a time horizon from hospitalization to 15 days post-discharge. Patient level direct health care costs and indirect costs were included. Health resource use, costs, and clinical outcomes were obtained from trial data. Publicly available pricing resources were used to supplement costs. Ranges for sensitivity analysis were based on 95% confidence intervals of the trial data. All costs were reported in 2021 Canadian dollars.InterventionsIntermittent (every 4 hours) vs continuous pulse oximetry using an oxygen saturation target of 90% or higher.Main outcomes and measuresCosts and incremental costs.ResultsTrial data from 229 infants (median [IQR] age, 4.0 [2.2-8.5] months; 136 boys [59.4%], 93 girls [40.6%]) were included. Mean societal costs per patient were $6879 (95% CI, $3393 to $12 317) in the intermittent and $7428 (95% CI, $1743 to $25 011) in the continuous group with a mean incremental cost of -$548 (95% CI, -$18 486 to $8105). Mean health care system costs per patient were $4195 (95% CI, $1191 to $9461) in the intermittent and $4716 (95% CI, $335 to $22 093) in the continuous group (incremental cost, -$520; 95% CI, -$18 286 to $7358). The mean effect measure of length of stay was similar between the 2 groups: 37.4 hours (95% CI, 1.0 to 137.7 hours) in the intermittent group and 38.5 hours (95% CI, 0 to 237.1 hours) in the continuous group. One-way sensitivity analyses on all variables revealed that the findings were robust and the incremental costs were not sensitive to the uncertainty within the defined ranges.Conclusions and relevanceIn this prospective economic evaluation study, we found that costs were similar for intermittent and continuous pulse oximetry considering societal and health care perspectives. Given that clinical outcomes between monitoring strategies are comparable and that other practice considerations favor intermittent monitoring, these findings provide additional information that support the use of intermittent monitoring in hospitalized infants with stabilized bronchiolitis.

Project description:ImportanceThere is low level of evidence and substantial practice variation regarding the use of intermittent or continuous monitoring in infants hospitalized with bronchiolitis.ObjectiveTo compare the effect of intermittent vs continuous pulse oximetry on clinical outcomes.Design, setting, and participantsThis multicenter, pragmatic randomized clinical trial included infants 4 weeks to 24 months of age who were hospitalized with bronchiolitis from November 1, 2016, to May 31, 2019, with or without supplemental oxygen after stabilization at community and children's hospitals in Ontario, Canada.InterventionsIntermittent (every 4 hours, n = 114) or continuous (n = 115) pulse oximetry, using an oxygen saturation target of 90% or higher.Main outcomes and measuresThe primary outcome was length of hospital stay from randomization to discharge. Secondary outcomes included length of stay from inpatient unit admission to discharge and outcomes measured from randomization: medical interventions, safety (intensive care unit transfer and revisits), parent anxiety and workdays missed, and nursing satisfaction.ResultsAmong 229 infants enrolled (median [IQR] age, 4.0 [2.2-8.5] months; 136 [59.4%] male; 101 [44.1%] from community hospital sites), the median length of hospital stay from randomization to discharge was 27.6 hours (interquartile range [IQR], 18.8-49.6 hours) in the intermittent group and 25.4 hours (IQR, 18.3-47.6 hours) in the continuous group (difference of medians, 2.2 hours; 95% CI, -1.9 to 6.3 hours; P = .17). No significant differences were observed between the intermittent and continuous groups in the median length of stay from inpatient unit admission to discharge: 49.1 (IQR, 37.2-87.0) hours vs 46.0 (IQR, 32.5-73.8) hours (P = .13) or in frequencies or durations of hospital interventions, such as oxygen supplementation initiation: 4 of 114 (3.5%) vs. 9 of 115 (7.8%) (P = .16) and median duration of oxygen supplementation: 20.6 (IQR, 7.6-46.1) hours vs. 21.4 (11.6-52.9) hours (P = .66). Similarly, there were no significant differences in frequencies of intensive care unit transfer: 1 of 114 (0.9%) vs 2 of 115 (2.7%) (P = .76); readmission to hospital: 3 of 114 (2.6%) in the intermittent group vs 4 of 115 (3.5%) in the continuous group (P > .99); parent anxiety: mean (SD) parent anxiety score, 2.9 (0.9) in the intermittent group vs 2.8 (0.9) in the continuous group (P = .40); or parent workdays missed: median workdays missed, 1.5 (IQR, 0.5-3.0) vs 1.5 (IQR, 0.5-2.5) (P = .36). Mean (SD) nursing satisfaction with monitoring was significantly greater in the intermittent group: 8.6 (1.7) vs 7.1 (2.8) of 10 workdays; the mean difference was 1.5 (95% CI, 0.9-2.2; P < .001).Conclusions and relevanceIn this randomized clinical trial, among infants hospitalized with stabilized bronchiolitis with and without hypoxia and managed using an oxygen saturation target of 90% or higher, clinical outcomes, including length of hospital stay and safety, were similar with intermittent vs continuous pulse oximetry. Nursing satisfaction was greater with intermittent monitoring. Given that other important clinical practice considerations favor less intense monitoring, these findings support the standard use of intermittent pulse oximetry in stable infants hospitalized with bronchiolitis.Trial registrationClinicalTrials.gov Identifier: NCT02947204.

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Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial.

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Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial.

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