Evaluation of Preterm NAVA Catheter PlacementPIPINCT05107713
Positioning of EDI Catheter In Premature Infants
An observational study of Evaluation of Preterm NAVA Catheter Placement, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Nasogastric (NG) and orogastric (OG) feeding tubes have a high incidence of malpositioning, occurring in up to 59% of preterm infants (Lopes 2019). Ideally, the tip of the feeding tube (including the orifices) should be located within the body of the stomach. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Evaluation of Preterm NAVA Catheter Placement
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 3 May 2023
- 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 1 day to 1 year
- All sexes
- Child
Study population: All babies, irrespective of GA, whose current weight is 400-2000g, who are: * about to be equipped OR already equipped with a 6F or 8F (49 or 50 cm) Edi feeding tube for clinical or research purposes. * Babies who are prescribed clinically or for research purposes, to have a chest/abdominal radiograph. Babies may be breathing on NAVA, NIV-NAVA or neural monitoring during a conventional mode or HFO, or nCPAP/HFNC. * Placement of a second feeding tube is permitted, as well as oral or nasal feeding tube insertion
Who may be able to join
None listed.
Who cannot join
- Patient exclusion criteria:
- Previous gastric surgery, anatomical abnormalities. Further reasons for exclusion will be left to the clinicians at each site.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Nasogastric (NG) and orogastric (OG) feeding tubes have a high incidence of malpositioning, occurring in up to 59% of preterm infants (Lopes 2019). Ideally, the tip of the feeding tube (including the orifices) should be located within the body of the stomach.
Malpositioning of the feeding tube can be classified as (i) being "too far out" where the tip of the catheter is located in the esophagus above the gastro-esophageal junction, potentially resulting in reflux, aspiration, apnea or (ii) being inserted "too far in" where the tip is located in the pylorus or the duodenum, leading to malabsorption of nutrients, diarrhea, and poor weight gain. Feeding tubes can also be found "curled up" inside the stomach (Quandt 2009) as much as 35% of the time. As well, one cannot ignore the risk of perforation, where the incidence has been reported to be 1.1% in extremely low birth weight (ELBW) infants (<1000g) (n = 7/646) (Thanhaeuser M, 2019); of note: perforations occurred on the third day of life (range days 2-14) not during initial feeding tube placement.
Read more
In 2008, a modified feeding tube was introduced to the market (Maquet Critical Care AB), which contains sensors placed in its wall, 13 mm above the feeding orifices, used for measuring the electrical activity of the diaphragm (Edi) during spontaneous breathing. The Edi signal is then used to neurally control mechanical ventilation, or for neural monitoring of the breathing pattern (Sinderby 1999; Beck 2016). The so-called "Edi catheter" comes with the manufacturer's recommended insertion measurements and verification window. In the Servo-I, the insertion distance is provided by a formula on the catheter packaging. In the Servo-U and Servo-n, the calculation for predicted insertion is provided by a tool in the ventilator. There is no available, published data upon which the manufacturer's recommendations were based. It is possible that obtaining appropriate positioning of the Edi catheter - based on a pattern of electrical signals from the sensors - could reduce the incidence of malposition.
This proposed study is observational, and non-interventional. The purpose is to verify the position of a neurally guided, clinically-placed, Edi catheter using radiography (Ellett 2011). We will also record physical measurements and weights of the babies in order to validate previously described methods of predicting insertion length. The x-rays will be taken with "near-simultaneous" screenshots of the Edi catheter positioning window.
Read the detailed description
Nasogastric (NG) and orogastric (OG) feeding tubes have a high incidence of malpositioning, occurring in up to 59% of preterm infants (Lopes 2019). Ideally, the tip of the feeding tube (including the orifices) should be located within the body of the stomach.
Malpositioning of the feeding tube can be classified as (i) being "too far out" where the tip of the catheter is located in the esophagus above the gastro-esophageal junction, potentially resulting in reflux, aspiration, apnea or (ii) being inserted "too far in" where the tip is located in the pylorus or the duodenum, leading to malabsorption of nutrients, diarrhea, and poor weight gain. Feeding tubes can also be found "curled up" inside the stomach (Quandt 2009) as much as 35% of the time. As well, one cannot ignore the risk of perforation, where the incidence has been reported to be 1.1% in extremely low birth weight (ELBW) infants (<1000g) (n = 7/646) (Thanhaeuser M, 2019); of note: perforations occurred on the third day of life (range days 2-14) not during initial feeding tube placement.
In 2008, a modified feeding tube was introduced to the market (Maquet Critical Care AB), which contains sensors placed in its wall, 13 mm above the feeding orifices, used for measuring the electrical activity of the diaphragm (Edi) during spontaneous breathing. The Edi signal is then used to neurally control mechanical ventilation, or for neural monitoring of the breathing pattern (Sinderby 1999; Beck 2016). The so-called "Edi catheter" comes with the manufacturer's recommended insertion measurements and verification window. In the Servo-I, the insertion distance is provided by a formula on the catheter packaging. In the Servo-U and Servo-n, the calculation for predicted insertion is provided by a tool in the ventilator. There is no available, published data upon which the manufacturer's recommendations were based. It is possible that obtaining appropriate positioning of the Edi catheter - based on a pattern of electrical signals from the sensors - could reduce the incidence of malposition.
This proposed study is observational, and non-interventional. The purpose is to verify the position of a neurally guided, clinically-placed, Edi catheter using radiography (Ellett 2011). The investigators will also record physical measurements and weights of the babies in order to validate previously described methods of predicting insertion length. The x-rays will be taken with "near-simultaneous" screenshots of the Edi catheter positioning window.
The investigators plan on studying a convenience sample of 65 premature babies of varying weights, from 9 sites.
Objective of the study:
To determine if optimal positioning of the Edi catheter results in feeding holes in the stomach in neonates. The aim is to capture a screenshot of the Edi catheter positioning along with one radiograph.
Study design:
This is a multi-centre, observational study.
Procedures:
- Once the subject is enrolled, if not already inserted, the Edi catheter will be placed as guided by routine clinical practice and fixed in place.
- Data collection form will be completed.
- When the placement of the Edi catheter is deemed satisfactory (or may have already been in place), a screenshot or photograph of the catheter positioning window is taken. Clinicians should make an effort to capture a screenshot just prior to or immediately after the radiograph is done, taking effort to maintain the same patient positioning to prevent inadvertent migration of the Edi catheter.
- Radiograph taken.
- Send all info to J Beck: package would include de-identified data: Data collection form, screen shot, radiograph.
- De-identified data will be initially sent to a secure server at Neurovent Research Inc, for then transfer to St-Michael's Hospital (lead site).
Analysis:
Radiographs will be analyzed after-the-fact, by Dr. Kay North, without having information on the catheter positioning window. The location of the tip of the catheter will be classified into one of four categories: 1. Tube tip in esophagus. 2 Tube tip in the region of the GEJ. 3. Tube tip in the stomach. 4. Tube tip in the pylorus. Any other comments would be noted (e.g. curled up catheter, catheter tip impinging on the lateral gastric wall), (Quandt 2009).
Screenshot of positioning window. Two independent analysts from St-Michael's Hospital will determine diaphragm position on the array. With the 6 mm IED catheter we have a resolution of 12 mm.
The measurements on the data collection form about NEX, NEMU and ARHB will be correlated to catheter insertion distance.
Other data will be used for anthropometric information
- Keywords
- Neurally Adjusted Ventilatory Assist, NAVA catheter, Edi catheter, electrical activity of the diaphragm, feeding tube placement
What is being measured
The primary outcome is the main question the study is designed to answer.
position of NAVA catheter determined by xray
Radiographs of clinically placed catheters will be evaluated by an independent radiologist
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Nov 2021
- Primary completion3 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Preterm NAVA Catheter PlacementStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107713
- Sponsor's protocol ID
- 21-078
- Acronym
- PIPI
- Status last verified
- May 2023
- First submitted
- 25 Oct 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Radiographs will be analyzed by an independent radiologist
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positioning of EDI Catheter In Premature Infants
- ClinicalTrials.gov ID
- NCT05107713
- Acronym / sponsor ID
- PIPI / 21-078
- Keywords
- Neurally Adjusted Ventilatory Assist, NAVA catheter, Edi catheter, electrical activity of the diaphragm, feeding tube placement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 4 Nov 2021 (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.
Nasogastric (NG) and orogastric (OG) feeding tubes have a high incidence of malpositioning, occurring in up to 59% of preterm infants (Lopes 2019). Ideally, the tip of the feeding tube (including the orifices) should be located within the body of the stomach.
Malpositioning of the feeding tube can be classified as (i) being "too far out" where the tip of the catheter is located in the esophagus above the gastro-esophageal junction, potentially resulting in reflux, aspiration, apnea or (ii) being inserted "too far in" where the tip is located in the pylorus or the duodenum, leading to malabsorption of nutrients, diarrhea, and poor weight gain. Feeding tubes can also be found "curled up" inside the stomach (Quandt 2009) as much as 35% of the time. As well, one cannot ignore the risk of perforation, where the incidence has been reported to be 1.1% in extremely low birth weight (ELBW) infants (<1000g) (n = 7/646) (Thanhaeuser M, 2019); of note: perforations occurred on the third day of life (range days 2-14) not during initial feeding tube placement.
In 2008, a modified feeding tube was introduced to the market (Maquet Critical Care AB), which contains sensors placed in its wall, 13 mm above the feeding orifices, used for measuring the electrical activity of the diaphragm (Edi) during spontaneous breathing. The Edi signal is then used to neurally control mechanical ventilation, or for neural monitoring of the breathing pattern (Sinderby 1999; Beck 2016). The so-called "Edi catheter" comes with the manufacturer's recommended insertion measurements and verification window. In the Servo-I, the insertion distance is provided by a formula on the catheter packaging. In the Servo-U and Servo-n, the calculation for predicted insertion is provided by a tool in the ventilator. There is no available, published data upon which the manufacturer's recommendations were based. It is possible that obtaining appropriate positioning of the Edi catheter - based on a pattern of electrical signals from the sensors - could reduce the incidence of malposition.
This proposed study is observational, and non-interventional. The purpose is to verify the position of a neurally guided, clinically-placed, Edi catheter using radiography (Ellett 2011). We will also record physical measurements and weights of the babies in order to validate previously described methods of predicting insertion length. The x-rays will be taken with "near-simultaneous" screenshots of the Edi catheter positioning window.
Detailed description
Nasogastric (NG) and orogastric (OG) feeding tubes have a high incidence of malpositioning, occurring in up to 59% of preterm infants (Lopes 2019). Ideally, the tip of the feeding tube (including the orifices) should be located within the body of the stomach.
Malpositioning of the feeding tube can be classified as (i) being "too far out" where the tip of the catheter is located in the esophagus above the gastro-esophageal junction, potentially resulting in reflux, aspiration, apnea or (ii) being inserted "too far in" where the tip is located in the pylorus or the duodenum, leading to malabsorption of nutrients, diarrhea, and poor weight gain. Feeding tubes can also be found "curled up" inside the stomach (Quandt 2009) as much as 35% of the time. As well, one cannot ignore the risk of perforation, where the incidence has been reported to be 1.1% in extremely low birth weight (ELBW) infants (<1000g) (n = 7/646) (Thanhaeuser M, 2019); of note: perforations occurred on the third day of life (range days 2-14) not during initial feeding tube placement.
In 2008, a modified feeding tube was introduced to the market (Maquet Critical Care AB), which contains sensors placed in its wall, 13 mm above the feeding orifices, used for measuring the electrical activity of the diaphragm (Edi) during spontaneous breathing. The Edi signal is then used to neurally control mechanical ventilation, or for neural monitoring of the breathing pattern (Sinderby 1999; Beck 2016). The so-called "Edi catheter" comes with the manufacturer's recommended insertion measurements and verification window. In the Servo-I, the insertion distance is provided by a formula on the catheter packaging. In the Servo-U and Servo-n, the calculation for predicted insertion is provided by a tool in the ventilator. There is no available, published data upon which the manufacturer's recommendations were based. It is possible that obtaining appropriate positioning of the Edi catheter - based on a pattern of electrical signals from the sensors - could reduce the incidence of malposition.
This proposed study is observational, and non-interventional. The purpose is to verify the position of a neurally guided, clinically-placed, Edi catheter using radiography (Ellett 2011). The investigators will also record physical measurements and weights of the babies in order to validate previously described methods of predicting insertion length. The x-rays will be taken with "near-simultaneous" screenshots of the Edi catheter positioning window.
The investigators plan on studying a convenience sample of 65 premature babies of varying weights, from 9 sites.
Objective of the study:
To determine if optimal positioning of the Edi catheter results in feeding holes in the stomach in neonates. The aim is to capture a screenshot of the Edi catheter positioning along with one radiograph.
Study design:
This is a multi-centre, observational study.
Procedures:
- Once the subject is enrolled, if not already inserted, the Edi catheter will be placed as guided by routine clinical practice and fixed in place.
- Data collection form will be completed.
- When the placement of the Edi catheter is deemed satisfactory (or may have already been in place), a screenshot or photograph of the catheter positioning window is taken. Clinicians should make an effort to capture a screenshot just prior to or immediately after the radiograph is done, taking effort to maintain the same patient positioning to prevent inadvertent migration of the Edi catheter.
- Radiograph taken.
- Send all info to J Beck: package would include de-identified data: Data collection form, screen shot, radiograph.
- De-identified data will be initially sent to a secure server at Neurovent Research Inc, for then transfer to St-Michael's Hospital (lead site).
Analysis:
Radiographs will be analyzed after-the-fact, by Dr. Kay North, without having information on the catheter positioning window. The location of the tip of the catheter will be classified into one of four categories: 1. Tube tip in esophagus. 2 Tube tip in the region of the GEJ. 3. Tube tip in the stomach. 4. Tube tip in the pylorus. Any other comments would be noted (e.g. curled up catheter, catheter tip impinging on the lateral gastric wall), (Quandt 2009).
Screenshot of positioning window. Two independent analysts from St-Michael's Hospital will determine diaphragm position on the array. With the 6 mm IED catheter we have a resolution of 12 mm.
The measurements on the data collection form about NEX, NEMU and ARHB will be correlated to catheter insertion distance.
Other data will be used for anthropometric information
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Age groups
- Child
- Study population
- All babies, irrespective of GA, whose current weight is 400-2000g, who are: * about to be equipped OR already equipped with a 6F or 8F (49 or 50 cm) Edi feeding tube for clinical or research purposes. * Babies who are prescribed clinically or for research purposes, to have a chest/abdominal radiograph. Babies may be breathing on NAVA, NIV-NAVA or neural monitoring during a conventional mode or HFO, or nCPAP/HFNC. * Placement of a second feeding tube is permitted, as well as oral or nasal feeding tube insertion
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Previous gastric surgery, anatomical abnormalities. Further reasons for exclusion will be left to the clinicians at each site.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
position of NAVA catheter determined by xray
Time frame: 1 year
Radiographs of clinically placed catheters will be evaluated by an independent radiologist
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 6 May 2023.
- Individual participant dataSharing planned: Yes. Radiographs will be analyzed by an independent radiologist
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 Evaluation of Preterm NAVA Catheter Placement, run by Unity Health Toronto at 1 site in Canada.
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 0 inclusion and 3 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 May 2023. 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 Canada. 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?
position of NAVA catheter determined by xray (time frame: 1 year). 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 6 May 2023.