Maurice 2022.
Study characteristics | ||
Methods | Setting: single‐centre, France Design: RCT, 2 arms, parallel assignment, open‐label single‐blind Start date: 27 July 2016 (reported in protocol) Completion date: August 2020 (reported in protocol) |
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Participants | 351 men and woman aged ≥ 18 years randomised: experimental (GA) = 174, comparator (CSA) = 177 Received allocated intervention:
345 participants were analysed: GA = 169 and CSA = 176 Mean age: 72 years (range: 60–85 years) Gender (men/women): 188/157 Mean NIHSS score: 16 (score range: 10–22) Localisation of stroke in left hemisphere: GA = 84 (50%) and CSA = 90 (51%) 8 (4%) participants converted from CSA to GA Received IV r‐tPA before EVT: GA = 111 (66%) and CSA = 114 (65%) Diagnostic criteria: AIS with LVO in anterior cerebral circulation Inclusion criteria
Exclusion criteria
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Interventions | Experimental: GA
Comparator: CSA
Conversion from CSA to GA was standardised and allowed in the following situations: agitation or restlessness not allowing the EVT; vomiting not allowing the EVT; GCS < 8; deglutition disorders, severe hypoxaemia with oxygen saturation measured by pulse oximetry at < 96% with oxygen being delivered via high‐concentration mask (maximum 10 L/minute), respiratory rate > 35/minute, clinical signs of respiratory exhaustion |
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Outcomes | Primary outcome (specified)
Primary outcome (collected)
Secondary outcomes (specified)
Secondary outcomes (collected)
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Notes | Conflicts of interest: quote "Dr. Beloeil received speaking fees from AbbVie (Chicago, Illinois) and Aspen Pharmacare (Durban, South Africa) and is a member of an expert board for Orion Pharma (Espoo, Finland). The other authors declare no competing interests". Funding: quote "The GASS trial was supported by funding from the French Ministry of Health (Paris, France; National Clinical Research Hospital Program, 2015). The funding sources had no role in the trial design, trial conduct, data handling, data analysis, or writing and publication of the manuscript". Protocol: NCT02822144 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was centralized and computer generated, and each patient was given a unique randomization number (patient code)". |
Allocation concealment (selection bias) | Low risk | Quote: "patients underwent randomization in a 1:1 ratio to undergo either general anesthesia or conscious sedation". |
Blinding of participants and personnel (performance bias) | High risk | Not described, but due to the nature of the interventions, we assumed that blinding of personnel was not possible. |
Blinding of outcome assessment (detection bias) | Unclear risk | Quote: "the modified Rankin score was assessed by trained research nurses blinded to the randomization group". Comment: the author did not report blinding of secondary outcomes. |
Incomplete outcome data (attrition bias) | High risk | 4 lost to follow‐up. Crossover in 3 participants from CSA to GA and 8 participants from GA to CSA but were analysed as ITT. Consent withdrawal occurred in 5 participants in GA arm and 1 participant in CSA arm and excluded from ITT. Comment: the number of participants lost to follow‐up and consent withdrawal was considerable and generated an imbalance between groups. |
Selective reporting (reporting bias) | High risk | A high number of participants had the mRS score evaluated between 2 and 6 months (GA = 96% and CSA = 94%) and 6% of participants had the mRS were evaluated after 6 months. Comment: the variations in the time of mRS score evaluation might affect the neurological outcomes. |
Other bias | Low risk | No evidence of other bias related to this study. |