Ventilation-Associated PneumoniaNUTRIREA1NCT01137487
Study of Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates
A study testing monitoring of residual gastric volume and not monitoring of residual gastric volume in people with Ventilation-Associated Pneumonia, run by Centre Hospitalier Departemental Vendee at 6 sites in France.
Trial summary
Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilation-Associated Pneumonia
- What is being tested?
- monitoring of residual gastric volume and not monitoring of residual gastric volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 6 sitesFrance
- Study dates
- May 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment with invasive mechanical ventilation
- Feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation.
- Age over 18 years
- Informed consent
Who cannot join
- Mechanical ventilation started more than 36 hours before institution of enteral feeding
- Patients turned in the prone position at inclusion
- Abdominal surgery within 1 month before inclusion
- History of esophageal or gastric surgery
- EN via a gastrostomy or a jejunostomy
- Bleeding from esophagus, stomach or bowel
Show all 10Show fewer
- Moribund patient
- Age less than 18 years
- Pregnancy.
- No informed consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CH Angoulème - Réanimation Polyvalente
Angoulême
CHD Vendée - Service de Réanimation
La Roche-sur-Yon, 85000
CHU Limoges - Réanimation Polyvalente
Limoges
CHU Orléans - Réanimation Médicale
Orléans
CHU Poitier - Réanimation Médicale
Poitiers
CHU Tours - Réanimation Polyvalente
Tours
About this study
Official title: Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates in Mechanically Ventilated Patients Receiving Early Enteral Feeding: a Randomized-controlled Study
Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.
- Conditions
- Ventilation-Associated Pneumonia
- Being tested
- monitoring of residual gastric volume, not monitoring of residual gastric volume
- Keywords
- mechanical ventilation, enteral nutrition, Ventilation-Associated Pneumonia, residual gastric volume measurement, vomiting, gastro-oesophageal reflux, early enteral nutrition, Intensive care unit, Enteral Feeding
- Medical subject headings
- Vomiting, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring of residual gastric volumeProcedure or surgery
Also called Residual Gastric Volume Measurement
measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
not monitoring of residual gastric volumeProcedure or surgery
Also called Non residual Gastric Measurement
no measurements of residual gastric volume
| Study group | Role | What they receive |
|---|---|---|
| residual gastric volume | Other | Not described Receives: Procedure: monitoring of residual gastric volume |
| residual gastric volume not monitored | Other | Not described Receives: Procedure: not monitoring of residual gastric volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring
Measured: until weaning of mechanical ventilation (average : 14 days)
Secondary outcomes (2)
Mortality Rate
Measured: 28 days
Vomiting Rates
Measured: until weaning of mechanical ventilation (average : 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilation-Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean REIGNIER, MD, PhD, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137487
- Sponsor's protocol ID
- CHD069-09
- Acronym
- NUTRIREA1
- Status last verified
- Mar 2026
- First submitted
- 19 May 2010
- Last updated
- 6 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.
PubMed 23321763
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates in Mechanically Ventilated Patients Receiving Early Enteral Feeding: a Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT01137487
- Acronym / sponsor ID
- NUTRIREA1 / CHD069-09
- Conditions
- Ventilation-Associated Pneumonia
- Keywords
- mechanical ventilation, enteral nutrition, Ventilation-Associated Pneumonia, residual gastric volume measurement, vomiting, gastro-oesophageal reflux, early enteral nutrition, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Jun 2010 (estimated)
- Results
- Posted 6 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| residual gastric volume | Other | Procedure: monitoring of residual gastric volume |
| residual gastric volume not monitored | Other | Procedure: not monitoring of residual gastric volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Treatment with invasive mechanical ventilation
- Feeding via nasogastric tube within 36 hours after the initiation of endotracheal mechanical ventilation.
- Age over 18 years
- Informed consent
Key exclusion criteria (10 listed)
- Mechanical ventilation started more than 36 hours before institution of enteral feeding
- Patients turned in the prone position at inclusion
- Abdominal surgery within 1 month before inclusion
- History of esophageal or gastric surgery
- EN via a gastrostomy or a jejunostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monitoring of residual gastric volumeAlso: Residual Gastric Volume Measurementmeasurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation | Procedure or surgery | residual gastric volume |
| not monitoring of residual gastric volumeAlso: Non residual Gastric Measurementno measurements of residual gastric volume | Procedure or surgery | residual gastric volume not monitored |
Primary outcome
Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring
Time frame: until weaning of mechanical ventilation (average : 14 days)
2 secondary outcomes
Mortality Rate
Time frame: 28 days
Vomiting Rates
Time frame: until weaning of mechanical ventilation (average : 14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23321763Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.
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Nebulised Colistimethate Sodium to Prevent Pediatric Ventilator-associated Pneumonia
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B Lymphocyte Populations in the Pulmonary Microenvironment of Patients Under Mechanical Ventilation With or Without VAP (Ventilator-Associated Pneumonia)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean REIGNIER, MD, PhD principal investigator
CHD Vendée
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monitoring of residual gastric volume and not monitoring of residual gastric volume in people with Ventilation-Associated Pneumonia, run by Centre Hospitalier Departemental Vendee at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring (time frame: until weaning of mechanical ventilation (average : 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01137487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.