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| Name | Class |
|---|---|
| University Hospital, Tours | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| residual gastric volume | Other |
| |
| residual gastric volume not monitored | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monitoring of residual gastric volume | Procedure | measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring | until weaning of mechanical ventilation (average : 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | 28 days | |
| Vomiting Rates | until weaning of mechanical ventilation (average : 14 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean REIGNIER, MD, PhD | CHD Vendée | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Angoulème - Réanimation Polyvalente | Angoulême | France | ||||
| CHD Vendée - Service de Réanimation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23321763 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Residual Gastric Volume Not Monitored |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2010 |
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| not monitoring of residual gastric volume | Procedure | no measurements of residual gastric volume |
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| La Roche-sur-Yon |
| 85000 |
| France |
| CHU Limoges - Réanimation Polyvalente | Limoges | France |
| CHU Orléans - Réanimation Médicale | Orléans | France |
| CHU Poitier - Réanimation Médicale | Poitiers | France |
| CHU Tours - Réanimation Polyvalente | Tours | France |
not monitoring of residual gastric volume: no measurements of residual gastric volume |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Residual Gastric Volume Not Monitored | not monitoring of residual gastric volume: no measurements of residual gastric volume |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compare Ventilator Associated Pneumonia Rates in Patients Receiving Early Enteral Feeding Without Residual Gastric Volume (RGV) Monitoring and in Patients With RGV Monitoring | Posted | Count of Participants | Participants | until weaning of mechanical ventilation (average : 14 days) |
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| Secondary | Mortality Rate | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Vomiting Rates | Posted | Count of Participants | Participants | until weaning of mechanical ventilation (average : 14 days) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 222 | 0 | 222 | ||
| EG001 | Residual Gastric Volume Not Monitored | not monitoring of residual gastric volume: no measurements of residual gastric volume | 0 | 227 | 0 | 227 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Reignier | CHD Vendée | 02 51 44 65 72 | secretariat.recherche.clinique@chd-vendee.fr |
| Mar 17, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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