Memtsoudis 2012.
Methods | RCT with parallel groups Approved by the Hospital for Special Surgery Institutional Review Board (Protocol no. 28117) and written, informed consents obtained Site: Hospital for Special Surgery, New York, NY, USA Setting: hospital Dates of data collection: February 2009 to September 2010 |
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Participants | 26 participants scheduled for elective, primary lumbar decompression and fusion of ≤ 4 spinal levels Exclusion criteria: known previous lung pathology, use of immunosuppressants, renal failure with creatinine > 1.5 mg/dL, recent exposure to a ventilator or surgery during general anaesthesia (< 1 year), and ASA physical status ≥ III |
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Interventions |
Treatment group: tidal volume 6 mL/kg (IBW) and PEEP 8 cmH2O (n = 13) Control group: tidal volume 12 mL/kg (IBW) and no PEEP (n = 13) |
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Outcomes |
Relevant to this review
Others
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Notes | Funding: Department of Anesthesiology, Hospital for Special Surgery (Stavros G. Memtsoudis), and Clinical Translational Science Center (CTSC) grant: NIH UL1‐RR024996 (Yan Ma) Declaration of interest: none mentioned Volume per body weight: IBW: men: 50 + 0.91 (height in cm – 152.4); women 45.5 + 0.91 (height in cm – 152.4) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomly assigned by a computer generated list of random numbers." |
Allocation concealment (selection bias) | Low risk | Quote: "the allocation sequence was concealed from the research assistant in sequentially numbered, opaque, sealed, and stapled envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "patients, surgeons, and research assistants who were responsible for subsequent data collection were blinded to the randomization." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "one patient in the low tidal volume group withdrew consent for blood draws after randomization and surgery." |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Quote: "despite randomization, patients in the low volume group were older (P value = 0.01)." |