Mechanical Ventilation ComplicationGASTRIPEDNCT04119089
Gastric Ultrasound to Monitor Gastric Residual Volume
An observational study of Mechanical Ventilation Complication and Enteral Feeding Intolerance, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation. Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed… Read more about this study
- Who is it for?
- Ages 37 weeks to 18 years
- Conditions the study is for
- Mechanical Ventilation Complication, Enteral Feeding Intolerance
- What is being tested?
- Gastric ultrasound
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2020to 18 Dec 2021
- Phase
- Observational
- 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 37 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will be conducted in pediatric intensive care unit patients
Who may be able to join
- Children hospitalized in intensive care unit, requiring invasive or non-invasive mechanical ventilation for a foreseeable duration > 48 hours.
- Enteral nutrition that has been started for more than 48 hours and less than 7 days.
- Age between 37 weeks of post conceptual age and 18 years.
- Parental consent or consent by the person having parental authority.
Who cannot join
- Abdominal surgery ≤ 1 year
- History of esophageal, gastric, duodenal, or pancreatic surgery
- Enteral nutrition via jejunostomy or gastrostomy.
- Any situation contraindicating the mobilization of the child in the right lateral decubitus position (uncontrolled hemodynamic instability, unstable neurological injury ...)
Trial locations and contacts
1 site in 1 country.
France1 site
Service Anesthésie réanimation - Centre Hospitalier Hôpital Femme Mère Enfant Groupement Hospitalier Est - Hospices Civils de Lyon
Bron, 69500
About this study
Official title: Reliability of Gastric Suctioning Compared to Gastric Ultrasound for Residual Gastric Volume Monitoring in Intensive Care Unit Pediatric Patients
It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation.
Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP).
Read more
Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding.
Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP.
This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients.
Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients.
This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.
- Being tested
- Gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundOther
A first gastric ultrasound will be performed in the supine and the right lateral (RLD) decubitus position, allowing a qualitative analysis of the gastric contents (empty, liquid, solid, solid-liquid). The antral area will also be measured in both positions. The volume of gastric fluid content will be calculated according to the following formula: volume (ml) = -7,8 + (0,035 x antral area in RLD (mm²)) + 0,127 x age (month).
This examination will be immediately followed by the aspiration of gastric contents through the nasogastric tube used for enteral feeding, into 50-ml syringes, by a nurse blinded to the result of the first ultrasound examination. A second antral ultrasound examination will then be performed, by the same investigator blinded to the volume aspirated.
The occurrence of regurgitation and / or vomiting occurring within the 12 hours before and after the examination will be recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring.
Empty stomach is defined as the lack of any gastric content when performing the second gastric ultrasound, after aspiration of gastric contents.
Measured: Maximum 1 day (Second gastric ultrasound, performed once aspiration of gastric contents has been achieved)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start30 May 2020
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119089
- Sponsor's protocol ID
- 69HCL19_0653
- Acronym
- GASTRIPED
- Status last verified
- Jan 2022
- First submitted
- 7 Oct 2019
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Gastric Suctioning Compared to Gastric Ultrasound for Residual Gastric Volume Monitoring in Intensive Care Unit Pediatric Patients
- ClinicalTrials.gov ID
- NCT04119089
- Acronym / sponsor ID
- GASTRIPED / 69HCL19_0653
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 8 Oct 2019 (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.
It is currently recommended to start enteral nutrition early in intensive care unit children receiving invasive or non-invasive mechanical ventilation.
Gastrointestinal intolerance is the main complication related to early enteral feeding in intensive care unit patients, characterized by gastroparesis with delayed gastric emptying that may lead to regurgitations, vomiting, pulmonary aspiration, and potentially increased risk of ventilator-associated pneumonia (VAP).
Residual gastric volume (RGV) measurement had been recommended to monitor the tolerance to enteral nutrition in mechanically ventilated patients receiving early enteral feeding.
Nevertheless, several studies have challenged the usefulness of such RGV monitoring, showing that it led to reduced caloric intake without any benefits in terms of reducing the occurrence of vomiting and the incidence of VAP.
This lack of relationship between RGV monitored using gastric suctioning and the occurrence of regurgitation, aspiration and pneumonia may reflect the inaccuracy of the aspiration method used for the measurement of the RGV, as it has been reported in adult patients.
Gastric ultrasonography is a non-invasive and easy-to-use tool allowing accurate preoperative assessment of gastric contents, based on both qualitative examination of the gastric antrum and calculation of gastric content volume. Ultrasound examination of the antrum could therefore constitute an alternative to gastric suctioning for the monitoring of RGV in intensive care unit patients.
This prospective study aims to assess the reliability of the RGV monitoring based on gastric suctioning compared to ultrasound technique. Secondary endpoint is to assess whether increased gastric volume, aspirated or calculated by ultrasound, is an independent risk factor of regurgitation and / or vomiting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 37 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will be conducted in pediatric intensive care unit patients
Key inclusion criteria (4 listed)
- Children hospitalized in intensive care unit, requiring invasive or non-invasive mechanical ventilation for a foreseeable duration > 48 hours.
- Enteral nutrition that has been started for more than 48 hours and less than 7 days.
- Age between 37 weeks of post conceptual age and 18 years.
- Parental consent or consent by the person having parental authority.
Key exclusion criteria (4 listed)
- Abdominal surgery ≤ 1 year
- History of esophageal, gastric, duodenal, or pancreatic surgery
- Enteral nutrition via jejunostomy or gastrostomy.
- Any situation contraindicating the mobilization of the child in the right lateral decubitus position (uncontrolled hemodynamic instability, unstable neurological injury ...)
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 |
|---|---|---|
| Gastric ultrasoundA first gastric ultrasound will be performed in the supine and the right lateral (RLD) decubitus position, allowing a qualitative analysis of the gastric contents (empty, liquid, solid, solid-liquid). The antral area will also be measured in both positions. The volume of gastric fluid content will be calculated according to the following formula: volume (ml) = -7,8 + (0,035 x antral area in RLD (mm²)) + 0,127 x age (month). This examination will be immediately followed by the aspiration of gastric contents through the nasogastric tube used for enteral feeding, into 50-ml syringes, by a nurse blinded to the result of the first ultrasound examination. A second antral ultrasound examination will then be performed, by the same investigator blinded to the volume aspirated. The occurrence of regurgitation and / or vomiting occurring within the 12 hours before and after the examination will be recorded. | Other | – |
Primary outcome
Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring.
Time frame: Maximum 1 day (Second gastric ultrasound, performed once aspiration of gastric contents has been achieved)
Empty stomach is defined as the lack of any gastric content when performing the second gastric ultrasound, after aspiration of gastric contents.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Enteral Feeding Intolerance, run by Hospices Civils de Lyon at 1 site 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 4 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients with an empty stomach after aspiration of gastric contents performed for the residual gastric volume monitoring. (time frame: Maximum 1 day (Second gastric ultrasound, performed once aspiration of gastric contents has been achieved)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2022.