Skip to main content
. 2019 Nov 27;2019(11):CD012631. doi: 10.1002/14651858.CD012631.pub2

Girardis 2016.

Methods RCT
Participants Sample size: 480 (experimental 244, control 236)
Sex (male %): experimental 57%, control 56%
Age (median): experimental 65, control 63
Country: Italy
Setting: multidisciplinary ICU
Disease severity score: SAPS II score median 38
Inclusion criteria

  1. All patients aged 18 years or older and admitted to the ICU with an expected length of stay of 72 hours or longer


Exclusion criteria

  1. Age younger than 18 years

  2. Pregnancy

  3. ICU readmission

  4. A decision to withhold life‐sustaining treatment

  5. Immunosuppression or neutropenia

  6. Enrolment in another study

  7. Patients with acute decompensation of COPD and ARDS with a PaO2:FiO2 ratio of less than 150
Interventions Experimental: oxygen therapy was administered according to standard ICU practice; FiO2 of at least 0.4, allowing PaO2 values up to 150 mmHg and an SpO2 between 97% and 100%. If the SpO2 decreased below 95% to 97%, the FiO2 was increased to reach the target value of SpO2. Participants received FiO2 of 1.0 during intubation, airway suction, or hospital transfer.
Categorized by us as using a high target in the experimental group.
Control: oxygen therapy was administered at the lowest possible FiO2 to maintain the PaO2 between 70 and 100 mmHg or SpO2 values between 94% and 98%. FiO2 was gradually reduced or oxygen supplementation discontinued whenever the PaO2 or SpO2 exceeded 100 mmHg or 98%. Supplemental oxygen was administered only if SpO2 decreased below 94%.
Categorized by us as using a high target in the control group.
Co‐intervention: not specified
Duration: until ICU discharge
Outcomes

  1. ICU mortality

  2. New‐onset respiratory, cardiovascular, liver, and renal failure (defined as a SOFA score ≥ 3 for the corresponding organ) occurring 48 hours or more after ICU admission

  3. Need for reoperation in surgical patients

  4. Bloodstream, respiratory, and surgical site infections (according to Centers for Disease Control and Prevention definitions). Only microbiologically documented bloodstream and respiratory tract infections were considered.


Secondary outcomes not prespecified

  1. Hospital mortality

  2. Ventilation‐free hours during the ICU stay
Notes Email sent 6 December 2018 to Dr Girardis and reply was received.
The trial was funded by public grants.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk The randomization sequence was concealed from the researchers by use of sequentially numbered, closed, opaque envelopes that were opened after patient study inclusion.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not described; however, blinding of outcome assessment was clarified by email
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Results from intention‐to‐treat analyses are provided in the supplementary. 2 participants withdrew consent, randomization groups for these 2 participants were not reported, thus they could not be included in the sensitivity analysis on losses to follow‐up.
Outcome respiratory failure: 18 in experimental and 15 in control group were lost to follow‐up
Selective reporting (reporting bias) High risk The trial was registered retrospectively (NCT01319643)
Other bias High risk Early stopping bias: the trial was stopped after an interim analysis that was not pre‐planned