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. 2023 Apr 3;2023(4):CD004873. doi: 10.1002/14651858.CD004873.pub6

Gajdos 2010.

Study characteristics
Methods Randomised, double‐blind controlled trial
All interventions were administered with the physiotherapist staying alone with the infant in a room with a covered window pane. The therapists were not involved in the evaluation of time to recovery.
Participants Children aged 15 days to 24 months with first acute bronchiolitis and indication of hospitalisation, and 1 or more of the following criteria at admission: toxic aspect; apnoea or cyanosis; respiratory rate > 60/minute; pulse oxymetry < 95%; alimentary intake < 2/3 of the needs. Bronchiolitis was diagnosed on the basis of a history of upper respiratory tract infection and clinical findings consistent with bronchiolitis, including wheezing or wheezing with crackles and respiratory distress. Country: France.
N = 496 participants randomised and analysed: 246 allocated to the control group and 250 to the intervention group. Mean age 2 months, range 1.3 to 3.9 months. The control group presented with a higher proportion of RSV+ infants than the intervention group (76.4% vs 73.3%), as well as the proportion of cases of lung atelectasis diagnosed on chest X‐ray (12.9% vs 7.6%). Survival analyses of time to recovery were adjusted for prognostic baseline covariates, including atelectasis at randomisation and RSV infection.
Interventions Group 1: chest physiotherapy with increased exhalation technique plus assisted cough plus nasopharyngeal aspiration (N = 246)
Group 2: nasopharyngeal aspiration (N = 250)
Increased exhalation technique involved the generation of synchronised thoracic‐abdominal movement by the hands of the physiotherapist at the beginning of expiration with 1 hand on the thorax, meanwhile with the other on the abdomen, centred on the umbilicus, the physiotherapist applied an abdominal counterweight. The manoeuvre began at the end of the inspiratory plateau and was pursued until the end of expiration, according to the infant's thoraco‐pulmonary compliance and up to his or her chest wall and lung resistance limits. The procedure was repeated until meeting auscultation‐efficacy criteria (decrease or disappearance of wheezing and/or increase of rhonchi), but did not last longer than 10 to 15 minutes. The procedure was stopped in the case of respiratory status aggravation. If no spontaneous coughing occurred, coughing could be triggered by pressure on the suprasternal notch.
All interventions were administered 3 times a day.
Outcomes Primary outcome: time to recovery, defined in the study protocol as verifying, for at least 8 hours in a row, the following requirements: pulse oxymetry >= 95% AND normal feeding AND specific respiratory distress score lower than 1 as described in the protocol AND normal respiratory rate
Secondary outcomes: safety of the forced expiratory technique; comparison of pulse oxymetry before/after chest physiotherapy; quality of life scale
Notes ClinicalTrials.gov identifier: NCT00125450
Study received funding from governmental organisations.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "random allocation computer generated with SAS software packages in advance by the biostatistician", "permutation blocks with a block size of four"
Allocation concealment (selection bias) Low risk "physiotherapist opening a sealed sequentially numbered envelope" "block size of four that was not mentioned to the physicians involved in the patient recruitment"
Blinding (performance bias and detection bias)
All outcomes Low risk "all paediatric department staff, parents and guardians were blind to treatment assignment." "Those involved in the evaluation of primary outcome or in the decision of the co interventions were blinded to group assignment." "The treatment was performed by the physiotherapist staying alone with the infant, in a room with a covered window pane"
Incomplete outcome data (attrition bias)
All outcomes Low risk "Analysis was performed on an intent‐to‐treat basis and all patients included in the study were analysed, including the two lost to follow‐up (one in each group)"
Selective reporting (reporting bias) Low risk Protocol available and consistent with report.
Other bias Low risk No other biases identified.