Ventilator Associated PneumoniaNCT06059040
Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events
A study testing eliminating gastric residual volume monitoring in people with Ventilator Associated Pneumonia, run by Damanhour University.
Trial summary
The aims of this study are to investigate the effect of eliminating routine GRV monitoring on VAEs in patients receiving MV and early EF, Determine the effect of eliminating routine GRV monitoring on nutritional adequacy in patients receiving MV and early EF and evaluate the effect of eliminating routine GRV… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- eliminating gastric residual volume monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (aged≥18 years)
- Newly admitted mechanically ventilated patients who are attached to a mechanical ventilator for at least 48 hours.
- Starting enteral nutrition via a nasogastric tube within 36 hours after intubation.
Who cannot join
- Abdominal surgery within the past month.
- History of esophageal, duodenal, pancreatic, or gastric surgery.
- Bleeding from the esophagus, stomach, or bowel.
- Enteral nutrition via a jejunostomy or gastrostomy.
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Eliminating Routine Gastric Residual Volume Monitoring on Ventilator-associated Events in Patients Receiving Enteral Feeding
The aims of this study are to investigate the effect of eliminating routine GRV monitoring on VAEs in patients receiving MV and early EF, Determine the effect of eliminating routine GRV monitoring on nutritional adequacy in patients receiving MV and early EF and evaluate the effect of eliminating routine GRV monitoring on feeding intolerance in patients receiving enteral feeding.
Read the detailed description
Early enteral nutrition (EN) is consistently recommended as first line nutrition therapy in critically ill patients since it favorably alters outcome, providing both nutrition and non-nutrition benefits. However, critically ill patients receiving mechanical ventilation (MV) are at risk for regurgitation, pulmonary aspiration, and eventually ventilator-associated pneumonia (VAP). EN may increase these risks when gastrointestinal (GI) dysfunction is present. Gastric residual volume (GRV) is considered a surrogate parameter of GI dysfunction during the progression of enteral feeding in the early phase of critical illness and beyond. About 62% of critically ill patients receive enteral nutrition (EN) and in patients on MV, enteral feeding was connected to a threefold increase in the development of VAP.
A new surveillance definition of ventilator-associated events (VAE) was introduced by the National Healthcare Safety Network (NHSN) in 2013 to identify patients who develop complications of MV. It outlines the various events in a step-by-step fashion, beginning with ventilator-associated complications (VAC), moving on to infectious complications (IVAC), and finally VAP. According to the NHSN, VAEs occur within 9% to 40% of mechanically ventilated patients
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- eliminating gastric residual volume monitoring
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eliminating gastric residual volume monitoringProcedure or surgery
eliminating gastric residual volume monitoring from routine care
| Study group | Role | What they receive |
|---|---|---|
| intervention groups | Active comparator | Patients in the intervention group will not be monitored for GRV (no GRV monitoring) and will be evaluated for the presence of feeding intolerance indicators such as vomiting, regurgitation, and abdominal distention. Receives: Procedure: eliminating gastric residual volume monitoring |
| control group | No intervention | Patients in the control group will be subjected to GRV monitoring (with GRV monitoring). |
What is being measured
The primary outcome is the main question the study is designed to answer.
eliminating gastric residual volume monitoring on ventilator associated events
use centers for disease control and prevention (CDC) calculators for evaluating VAE version 9.0 2021
Measured: 3 month
Secondary outcomes (2)
eliminating gastric residual volume monitoring on nutritional adequacy
evaluation daily caloric requirement by body mass index that calculated using the equation (Weight in kg /height in cm) 2
Measured: 3 month
eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators
evaluation of abdominal circumference, abdominal distension, bowel sounds, the episodes of vomiting and diarrhea
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel randomized controlled design will be used in this study.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059040
- Sponsor's protocol ID
- elimination GRV monitor on VAE
- Status last verified
- Aug 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yasuda H, Kondo N, Yamamoto R, Asami S, Abe T, Tsujimoto H, Tsujimoto Y, Kataoka Y. Monitoring of gastric residual volume during enteral nutrition. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013335. doi: 10.1002/14651858.CD013335.pub2.
PubMed 34596901Reignier 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 23321763Wang Z, Ding W, Fang Q, Zhang L, Liu X, Tang Z. Effects of not monitoring gastric residual volume in intensive care patients: A meta-analysis. Int J Nurs Stud. 2019 Mar;91:86-93. doi: 10.1016/j.ijnurstu.2018.11.005. Epub 2019 Jan 3.
PubMed 30677592
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eliminating Routine Gastric Residual Volume Monitoring on Ventilator-associated Events in Patients Receiving Enteral Feeding
- ClinicalTrials.gov ID
- NCT06059040
- Acronym / sponsor ID
- elimination GRV monitor on VAE
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are to investigate the effect of eliminating routine GRV monitoring on VAEs in patients receiving MV and early EF, Determine the effect of eliminating routine GRV monitoring on nutritional adequacy in patients receiving MV and early EF and evaluate the effect of eliminating routine GRV monitoring on feeding intolerance in patients receiving enteral feeding.
Detailed description
Early enteral nutrition (EN) is consistently recommended as first line nutrition therapy in critically ill patients since it favorably alters outcome, providing both nutrition and non-nutrition benefits. However, critically ill patients receiving mechanical ventilation (MV) are at risk for regurgitation, pulmonary aspiration, and eventually ventilator-associated pneumonia (VAP). EN may increase these risks when gastrointestinal (GI) dysfunction is present. Gastric residual volume (GRV) is considered a surrogate parameter of GI dysfunction during the progression of enteral feeding in the early phase of critical illness and beyond. About 62% of critically ill patients receive enteral nutrition (EN) and in patients on MV, enteral feeding was connected to a threefold increase in the development of VAP.
A new surveillance definition of ventilator-associated events (VAE) was introduced by the National Healthcare Safety Network (NHSN) in 2013 to identify patients who develop complications of MV. It outlines the various events in a step-by-step fashion, beginning with ventilator-associated complications (VAC), moving on to infectious complications (IVAC), and finally VAP. According to the NHSN, VAEs occur within 9% to 40% of mechanically ventilated patients
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel randomized controlled design will be used in this study.
| Arm | Type | Receives |
|---|---|---|
| intervention groups | Active comparator | Procedure: eliminating gastric residual volume monitoringPatients in the intervention group will not be monitored for GRV (no GRV monitoring) and will be evaluated for the presence of feeding intolerance indicators such as vomiting, regurgitation, and abdominal distention. |
| control group | No intervention | –Patients in the control group will be subjected to GRV monitoring (with GRV monitoring). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults (aged≥18 years)
- Newly admitted mechanically ventilated patients who are attached to a mechanical ventilator for at least 48 hours.
- Starting enteral nutrition via a nasogastric tube within 36 hours after intubation.
Key exclusion criteria (5 listed)
- Abdominal surgery within the past month.
- History of esophageal, duodenal, pancreatic, or gastric surgery.
- Bleeding from the esophagus, stomach, or bowel.
- Enteral nutrition via a jejunostomy or gastrostomy.
- Pregnancy
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 |
|---|---|---|
| eliminating gastric residual volume monitoringeliminating gastric residual volume monitoring from routine care | Procedure or surgery | intervention groups |
Primary outcome
eliminating gastric residual volume monitoring on ventilator associated events
Time frame: 3 month
use centers for disease control and prevention (CDC) calculators for evaluating VAE version 9.0 2021
2 secondary outcomes
eliminating gastric residual volume monitoring on nutritional adequacy
Time frame: 3 month
eliminating gastric residual volume monitoring on incidence of feeding intolerance indicators
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 34596901Yasuda H, Kondo N, Yamamoto R, Asami S, Abe T, Tsujimoto H, Tsujimoto Y, Kataoka Y. Monitoring of gastric residual volume during enteral nutrition. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013335. doi: 10.1002/14651858.CD013335.pub2.
- Background: 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.
- Background: PubMed 30677592Wang Z, Ding W, Fang Q, Zhang L, Liu X, Tang Z. Effects of not monitoring gastric residual volume in intensive care patients: A meta-analysis. Int J Nurs Stud. 2019 Mar;91:86-93. doi: 10.1016/j.ijnurstu.2018.11.005. Epub 2019 Jan 3.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing eliminating gastric residual volume monitoring in people with Ventilator Associated Pneumonia, run by Damanhour University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enas Abdel sadek, Demonstrator (01093168809, Enas_shoeab@nur.edu.dam.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eliminating gastric residual volume monitoring on ventilator associated events (time frame: 3 month). 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 NCT06059040, which also lists 3 linked publications.
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 28 Sep 2023.