Healthy VolunteersLEGENDNCT03520582
Placement of Novel Endoscopic Enteral Feeding Tube
An observational study of Healthy Volunteers and Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Enteral Feeding
- What is being tested?
- Tube placement
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Nov 2017to 30 Jul 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient in ICU mechanically ventilated and requiring a placement of a postpyloric feeding tube
Who may be able to join
- Healthy volunteers
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age >18 years
- Patients
- Age >18 years
- mechanically ventilated and requiring a placement of a postpyloric feeding tube on clinical indications
- Informed Consent as documented by signature of relatives
Who cannot join
- Healthy volunteers and patients
- Unrepaired tracheoesophageal fistula
- history of prior esophageal or gastric surgery
- esophageal obstruction, stricture, varices or diverticulum
- esophageal or gastric perforation, gastric or esophageal bleeding
- recent oropharyngeal surgery
Show all 9Show fewer
- cervical spine injury or anomaly
- Additional exclusion criterion for patients only
- know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) > 3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.
Read the detailed description
Enteral feeding is the preferred route of nutrient delivery in hospitalized patients who cannot eat sufficiently. Placement of enteral feeding tubes carries a risk of misplacement especially in patients who are unable to fully collaborate during the tube placement due to neurological impairment and/or the presence of an artificial airway. The misplacement of a feeding tube in the airways has a high risk of severe complications, including pneumonia, mechanical damage of airways and the lung, and death. The verification of correct tube placement can be done using radiography, or interventions aimed at confirming the location of the tube tip by aspiration of gastric contents, and by auscultation during injection of air.
Approximately 20-25 % of patients treated in intensive care units are likely to need placement of a feeding tube, while undergoing mechanical ventilation and having an artificial airway. This high risk patient group would benefit from technologies allowing direct visualization of tube placement. It is also expected that direct visualization of tube placement will allow confirmation of tube placement and therefore eliminate the need of radiography (radiation).
- Conditions
- Healthy Volunteers, Enteral Feeding
- Being tested
- Tube placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube placementDevice
Placement of enteral feeding tubes
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Cohort of 10 healthy subjects. The tube will be placed and removed by a gastroenterologist experienced in performing endoscopic postpyloric tube placement. Secondly, a second tube will be placed and removed. Receives: Device: Tube placement | |
| Mechanically ventilated ICU | Cohort of 20 mechanically ventilated intensive care patients requiring a placement of a postpyloric feeding tube on clinical indications. Receives: Device: Tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality.
using a visual analog scale of 1-10, with 1 indicating the best value
Measured: During Intervention Visit, an average of 24 hours
Secondary outcomes (13)
In healthy volunteers, time required to reach gastric and postpyloric placement
Questionnaire with various positions and the time to reach the position
Measured: During Intervention Visit, an average of 24 hours
In healthy volunteers, ease of insertion, handling, and image quality assessed
Using a visual analog scale of 1-10, with 1 indicating the best value
Measured: During Intervention Visit, an average of 24 hours
In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction
Using a visual analog scale of 1-10, with 1 indicating the best value.
Measured: During Intervention Visit, an average of 24 hours
In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation.
Questionnaire Yes/No and a visual analog scale of 1-10, with 1 indicating the best value
Measured: During Intervention Visit, an average of 24 hours
In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value.
using a visual analog scale of 1-10, with 1 indicating the best value
Measured: During Intervention Visit, an average of 24 hours
In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction.
using a visual analog scale of 1-10, with 1 indicating the best value
Measured: During Intervention Visit, an average of 24 hours
In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients.
using a visual analog scale of 1-10, with 1 indicating the best value
Measured: During Intervention Visit, an average of 24 hours
In patients: Time required to reach gastric and postpyloric placement
Questionnaire
Measured: During Intervention Visit, an average of 24 hours
In patients: Feasibility of the feeding through Veritract tube.
using a visual analog scale of 1-10, with 1 indicating the best value
Measured: During Intervention Visit, an average of 24 hours
Bleeding and infection related to tube placement
AE/SAE Questionnaire Yes/No
Measured: During Intervention Visit, an average of 24 hours
Erroneous placement in larynx and trachea and associated complications (pneumothorax).
Outcome mesured with a questionnaire Yes/No
Measured: During Intervention Visit, an average of 24 hours
Injuries of the oesophagus, stomach or small intestine related to tube placement.
Outcome mesured with a questionnaire Yes/No
Measured: During Intervention Visit, an average of 24 hours
Reflux of stomach contents during tube placement
AE/SAE Questionnaire Yes/No
Measured: During Intervention Visit, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start6 Nov 2017
- Primary completion7 Jun 2018
- Study completion30 Jul 2018
Why it stopped: stop trial due to proposals for possible optimizations of the device by the investigators.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Cohort
- Time perspective
- Other
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Merz, Dr. med., Principal investigator, Inselspital Bern, Universitätsklinik für Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520582
- Sponsor's protocol ID
- 16.22.CLI
- Acronym
- LEGEND
- Status last verified
- Sep 2018
- First submitted
- 22 Dec 2016
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
- ClinicalTrials.gov ID
- NCT03520582
- Acronym / sponsor ID
- LEGEND / 16.22.CLI
- Conditions
- Healthy Volunteers, Enteral Feeding
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: stop trial due to proposals for possible optimizations of the device by the investigators.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 11 May 2018 (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 aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.
Detailed description
Enteral feeding is the preferred route of nutrient delivery in hospitalized patients who cannot eat sufficiently. Placement of enteral feeding tubes carries a risk of misplacement especially in patients who are unable to fully collaborate during the tube placement due to neurological impairment and/or the presence of an artificial airway. The misplacement of a feeding tube in the airways has a high risk of severe complications, including pneumonia, mechanical damage of airways and the lung, and death. The verification of correct tube placement can be done using radiography, or interventions aimed at confirming the location of the tube tip by aspiration of gastric contents, and by auscultation during injection of air.
Approximately 20-25 % of patients treated in intensive care units are likely to need placement of a feeding tube, while undergoing mechanical ventilation and having an artificial airway. This high risk patient group would benefit from technologies allowing direct visualization of tube placement. It is also expected that direct visualization of tube placement will allow confirmation of tube placement and therefore eliminate the need of radiography (radiation).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Device: Tube placementCohort of 10 healthy subjects. The tube will be placed and removed by a gastroenterologist experienced in performing endoscopic postpyloric tube placement. Secondly, a second tube will be placed and removed. |
| Mechanically ventilated ICU | – | Device: Tube placementCohort of 20 mechanically ventilated intensive care patients requiring a placement of a postpyloric feeding tube on clinical indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient in ICU mechanically ventilated and requiring a placement of a postpyloric feeding tube
Key inclusion criteria (7 listed)
- Healthy volunteers
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age >18 years
- Patients
- Age >18 years
Key exclusion criteria (9 listed)
- Healthy volunteers and patients
- Unrepaired tracheoesophageal fistula
- history of prior esophageal or gastric surgery
- esophageal obstruction, stricture, varices or diverticulum
- esophageal or gastric perforation, gastric or esophageal bleeding
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 |
|---|---|---|
| Tube placementPlacement of enteral feeding tubes | Device | Mechanically ventilated ICU, Volunteers |
Primary outcome
Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality.
Time frame: During Intervention Visit, an average of 24 hours
using a visual analog scale of 1-10, with 1 indicating the best value
13 secondary outcomes
In healthy volunteers, time required to reach gastric and postpyloric placement
Time frame: During Intervention Visit, an average of 24 hours
In healthy volunteers, ease of insertion, handling, and image quality assessed
Time frame: During Intervention Visit, an average of 24 hours
In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction
Time frame: During Intervention Visit, an average of 24 hours
In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation.
Time frame: During Intervention Visit, an average of 24 hours
In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value.
Time frame: During Intervention Visit, an average of 24 hours
In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction.
Time frame: During Intervention Visit, an average of 24 hours
In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients.
Time frame: During Intervention Visit, an average of 24 hours
In patients: Time required to reach gastric and postpyloric placement
Time frame: During Intervention Visit, an average of 24 hours
In patients: Feasibility of the feeding through Veritract tube.
Time frame: During Intervention Visit, an average of 24 hours
Bleeding and infection related to tube placement
Time frame: During Intervention Visit, an average of 24 hours
Erroneous placement in larynx and trachea and associated complications (pneumothorax).
Time frame: During Intervention Visit, an average of 24 hours
Injuries of the oesophagus, stomach or small intestine related to tube placement.
Time frame: During Intervention Visit, an average of 24 hours
Reflux of stomach contents during tube placement
Time frame: During Intervention Visit, an average of 24 hours
Results and safety
The study was stopped early (reason given: stop trial due to proposals for possible optimizations of the device by the investigators.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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Screening Protocol
Pain
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.
Tobias Merz, Dr. med. principal investigator
Inselspital Bern, Universitätsklinik für Intensivmedizin
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 Healthy Volunteers and Enteral Feeding, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Sep 2018. 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 Switzerland. 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 was stopped early (reason given: stop trial due to proposals for possible optimizations of the device by the investigators.). Results are not available in the source record.
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?
Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality. (time frame: During Intervention Visit, an average of 24 hours). 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 7 Sep 2018.