Admon (2019)

Hypoxemia

Intensive care • Rcts Data • US

Study Metrics
Total Sample 360
Treatment Group 180
Control Group 180
Covariates 11
PICO Comparisons 10
Quality Indicators
Transparency High
DAG Usage No
QBA Performed No

Study Information

First Author: Admon
Publication Year: 2019
DOI: https://doi.org/10.1513/AnnalsATS.201903-241OC
Preprint: No preprint

Institution & Funding

Institution Type: Academic
Institutions: University of Michigan, Veterans Affairs Center, Vanderbilt University Medical Center, Louisiana State University School of Medicine, University of Alabama at Birmingham, University of Washington, Ochsner Health System New Orleans, Lahey Hospital and Medical Center
Funding: Declared: Public
Funding Institutions: U.S. National Heart, Lung, and Blood Institute grants T32HL007749 (A.J.A.), K12HL138039 (J.P.D.), T32HL087738 (J.D.C.), and K23HL143053 (M.W.S.), and by U.S. Department of Veterans Affairs Health Services Research and Development grant 17-045 (T.J.I.).

Study Context

Disease: Hypoxemia
Disease Category: Intensive care
Data Type: rcts
Number of Data Sources: 3
Geography: US
Eligible Sample: 360.0
Number of Treatments: 2

Analytical Methods

Missing Data Method: Multiple imputation
Matching Method: PS matching
Analysis Method: linear regression

Quality Methods

Directed Acyclic Graph (DAG) Not Used
Quantitative Bias Analysis (QBA) Not Performed

Target Trial Information

Target Trial Name: PreVent
Registration Number: NCT03026322
Target Trial DOI: https://doi.org/10.1056/NEJMoa1812405

TTE vs RCT Comparisons

Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.

Cardiac arrest 1 h after intubation
PreVent
RR Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

Cardiac arrest 1 h after intubation

RCT Result

2.00

95% CI: [0.40, 10.80]


vs
TTE Result

0.76

95% CI: [0.20, 3.40]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions
Decrease in oxygen saturation %
PreVent
MD Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

Decrease in oxygen saturation %

RCT Result

-1.90

95% CI: [-4.50, 0.80]


vs
TTE Result

-4.50

95% CI: [-6.80, -2.20]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
Died before hospital discharge
PreVent
RR Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

Died before hospital discharge

RCT Result

1.00

95% CI: [0.80, 1.30]


vs
TTE Result

1.00

95% CI: [0.80, 1.30]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
ICU-free days
PreVent
MD Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

ICU-free days

RCT Result

0.10

95% CI: [-2.20, 2.40]


vs
TTE Result

0.80

95% CI: [-1.30, 2.90]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
lowest oxygen saturation %
PreVent
MD Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

lowest oxygen saturation %

RCT Result

3.90

95% CI: [1.40, 6.40]


vs
TTE Result

1.80

95% CI: [-1.00, 4.60]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
lowest oxygen saturation <70%
PreVent
RR Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

lowest oxygen saturation <70%

RCT Result

0.63

95% CI: [0.30, 1.30]


vs
TTE Result

0.41

95% CI: [0.20, 0.90]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
lowest oxygen saturation <80%
PreVent
RR Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

lowest oxygen saturation <80%

RCT Result

0.48

95% CI: [0.30, 0.77]


vs
TTE Result

0.60

95% CI: [0.38, 0.93]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
lowest oxygen saturation <90%
PreVent
RR Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

lowest oxygen saturation <90%

RCT Result

0.74

95% CI: [0.60, 1.00]


vs
TTE Result

0.89

95% CI: [0.70, 1.20]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Same Direction
Both point to similar conclusion
Operator-reported aspiration
PreVent
RR Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

Operator-reported aspiration

RCT Result

3.00

95% CI: [0.40, 10.80]


vs
TTE Result

0.64

95% CI: [0.20, 1.90]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions
Ventilator-free days
PreVent
MD Efficacy
Population

patients undergoing tracheal intubation

Intervention

positive-pressure ventilation with a bag- mask device or noninvasive ventilator (modi ed RSI)

Comparison

No positive-pressure ventilation except after a failed attempt or for SpO2 ,90% (classic RSI)

Outcome

Ventilator-free days

RCT Result

-0.50

95% CI: [-3.00, 1.90]


vs
TTE Result

0.60

95% CI: [-1.70, 2.90]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
Different conclusions

Transparency Indicators

Protocol Registration Available
Data Sharing Not Available
Code Sharing Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.

Conflicts & Funding

Conflicts of Interest: Declared: None
Funding Source: Declared: Public
Funding Institutions: U.S. National Heart, Lung, and Blood Institute grants T32HL007749 (A.J.A.), K12HL138039 (J.P.D.), T32HL087738 (J.D.C.), and K23HL143053 (M.W.S.), and by U.S. Department of Veterans Affairs Health Services Research and Development grant 17-045 (T.J.I.).