Del Amo Castrillo 2019.
Study characteristics | ||
Methods |
Study design: randomised, open, single‐centre, cross‐over study comparing breathstacking and mechanical insufflation using VCM, both using a home ventilator Study grouping: cross‐over 'Rescue' vs maintenance therapy: maintenance Ethics: ethical clearance obtained. All participants or caregivers (or both) provided informed consent |
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Participants |
Baseline characteristics (n = 20) Separate data were not available for group allocations in the first period of cross‐over. Data were presented for all participants who received all interventions.
Inclusion criteria
Exclusion criteria
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Interventions |
Intervention characteristics Breathstacking
Mechanical insufflation using ventilator VCM
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Outcomes | Separate first‐period data were not presented, precluding analysis. Primary outcome measures PCF
All measurements were taken with the participant in a sitting position. The PCF measurements were made using a pneumotachograph (Fleisch No. 4, Lausanne, Switzerland). Flow increases were linear at 600 L/min, therefore the volume measured during calibration with a syringe was not influenced by flows of 30–600 L/min. The flow signal was sampled at 1000 Hz and recorded using an analogue‐numeric system (MP100, Biopac System, Goleta, California, USA) and its software (AcqKnowledge).
Inspiratory capacity
Secondary outcome measures Subjective ratings of breathing comfort
Subjective ratings of cough effectiveness
Oxygen saturation and heart rate were recorded but not listed as primary or secondary outcome measures. Adverse events: not reported |
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Identification |
Sponsorship source: not stated Conflict of interest: the authors disclosed a relationship with ResMed France, the company who manufacture the VCM ventilator device. The exact nature of the relationship was unclear. Country: France Setting: home ventilation unit of the medical ICU of the Raymond Poincaré Teaching Hospital, Garxhes, France Comments: authors disclosed a relationship with ResMed, France First author name: Del Amo Castrillo Institution: Ms Del Amo Castrillo, Mr Lacombe, and Mr Bore were affiliated with the ICU at Hôpital Raymond Poincaré, AP‐HP, Garches, France. Ms Vaugier and Dr Orlikowski were affiliated with Hôpital Raymond Poincaré, INSERM CIC 1429, Garches, France. Ms Falaize and Dr Prigent, and Dr Lofaso were affiliated with Service de Physiologie‐Explorations Fonctionnelles, Hôpital Raymond Poincaré, AP‐HP, Garches, France Email: f.lofaso@rpc.aphp.fr Address: Frédéric Lofaso MD PhD, Services de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, AP‐HP, 92380, Garches, France |
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Notes | Study was approved by the French Ethics Committee (Comité de Protection des Personnes) of Saint‐Germain‐en‐Laye, France, on 3 September 2015 (NCPP15031) and registered on ClinicalTrials.gov as NCT02847299. Attempts to contact the trial author for additional data were unsuccessful. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "We used a randomized, open, single‐center, crossover design…" Comment: method of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not mentioned in the article. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "One physiotherapist and one technician carried out the tests, prevented leakage and performing measurements." Comment: the same personnel conducted all interventions and measurements, and, therefore, it was highly unlikely that they would have been blinded. The nature of the interventions suggested that participants could not have been blinded to allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "One physiotherapist and one technician carried out the tests, prevented leakage and performing measurements." Comment: all outcome assessments were measured by the same technician, who could not feasibly have been blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcome measures were reported for all participants. |
Selective reporting (reporting bias) | Low risk | Comment: all primary and secondary outcome measures were fully reported. |
Other bias | High risk | Comment: the following factors placed this study at high risk of other sources of bias.
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