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. 2021 Sep 27;2021(9):CD013335. doi: 10.1002/14651858.CD013335.pub2

Booker 2000.

Study characteristics
Methods Study design: parallel‐group RCT
Participants Country: USA
Setting: multi‐center; medical and surgical ICU
Inclusion criteria: receiving nutritional support through a gastric feeding tube with anticipated duration of tube feeding > 48 hours
Exclusion criteria: not reported
Baseline characteristics
  • Number randomized: 35

  • Number analyzed: 18

  • Intervention arm

    • Age (mean): 62.1 (range 18–77) years

    • Number of participants: 10

    • Gender (men/women; n): 5/5

  • Control arm

    • Age (mean): 58.9 (range 17–83) years

    • Number of participants: 8

    • Gender (men/women; n): 4/4

  • Baseline imbalances: comparable

Interventions Intervention arm
  • All GRV discarded (frequency of monitoring: no data)


Control arm
  • All GRV returned (frequency of monitoring: no data)


Loss to follow‐up: 17 participants withdrew from the trial: death (n = 2); transfer from ICU before completion of 3 days (n = 6); early removal of feeding tube (n = 5); missing data (n = 4). There was no mention of which arm these 17 participants belonged to.
Duration of follow‐up: 3 days
Duration of trial: September 1995 to June 1997
Outcomes Volume aspirated from stomach
Notes Funding source: Sigma Theta Tau, Delta Lambda Chapter, St Louis University
Conflict of interest: unknown
Clinical trial registration: unknown
Duration of follow‐up was changed from 7 days due to serious numbers of missing data.
Any disease severity scores of participants were not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk People who consented were assigned to treatment group randomly. Details of randomization methods not provided.
Allocation concealment (selection bias) Unclear risk Multi‐center (3 centers) study and often for such a study design, a centralized allocation method would be performed. However, for this study there were no further details on allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Unblinded.
Blinding of outcome assessment (detection bias)
All outcomes High risk Unblinded. For subjective outcomes, such as pneumonia and adverse events, the risk of detection bias would be high; for objective outcome measures, such as mortality, the risk of detection of bias would be low.
Incomplete outcome data (attrition bias)
All outcomes High risk Data for 17 participants were omitted from analysis.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias High risk Lack of full‐time clinical research monitoring by study investigators.