Trial Outcomes & Findings for Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates (NCT NCT01137487)
NCT ID: NCT01137487
Last Updated: 2026-04-06
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
452 participants
Primary outcome timeframe
until weaning of mechanical ventilation (average : 14 days)
Results posted on
2026-04-06
Participant Flow
Participant milestones
| Measure |
Residual Gastric Volume
monitoring of residual gastric volume: measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
|
Residual Gastric Volume Not Monitored
not monitoring of residual gastric volume: no measurements of residual gastric volume
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
230
|
|
Overall Study
COMPLETED
|
222
|
227
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Residual Gastric Volume
monitoring of residual gastric volume: measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
|
Residual Gastric Volume Not Monitored
not monitoring of residual gastric volume: no measurements of residual gastric volume
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Residual Gastric Volume
n=222 Participants
monitoring of residual gastric volume: measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
|
Residual Gastric Volume Not Monitored
n=227 Participants
not monitoring of residual gastric volume: no measurements of residual gastric volume
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 14 • n=222 Participants
|
61 years
STANDARD_DEVIATION 15 • n=227 Participants
|
62 years
STANDARD_DEVIATION 14 • n=449 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=222 Participants
|
68 Participants
n=227 Participants
|
134 Participants
n=449 Participants
|
|
Sex: Female, Male
Male
|
156 Participants
n=222 Participants
|
159 Participants
n=227 Participants
|
315 Participants
n=449 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
222 Participants
n=222 Participants
|
227 Participants
n=227 Participants
|
449 Participants
n=449 Participants
|
PRIMARY outcome
Timeframe: until weaning of mechanical ventilation (average : 14 days)Outcome measures
| Measure |
Residual Gastric Volume
n=222 Participants
measurements of residual gastric volume every six hours
|
Residual Gastric Volume Not Monitored
n=227 Participants
no measurements of residual gastric volume
|
|---|---|---|
|
Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring
|
35 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: 28 daysOutcome measures
| Measure |
Residual Gastric Volume
n=222 Participants
measurements of residual gastric volume every six hours
|
Residual Gastric Volume Not Monitored
n=227 Participants
no measurements of residual gastric volume
|
|---|---|---|
|
Mortality Rate
|
61 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: until weaning of mechanical ventilation (average : 14 days)Outcome measures
| Measure |
Residual Gastric Volume
n=222 Participants
measurements of residual gastric volume every six hours
|
Residual Gastric Volume Not Monitored
n=227 Participants
no measurements of residual gastric volume
|
|---|---|---|
|
Vomiting Rates
|
60 Participants
|
90 Participants
|
Adverse Events
Residual Gastric Volume
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Residual Gastric Volume Not Monitored
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place