Tracheal IntubationFlowNETNCT05162313
Flow Sensor and Colourimetric Capnometer in Verifying Tracheal Tube Positioning in Term and Preterm Infants
A study testing confirmation of endotracheal tube positioning in people with Tracheal Intubation, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
This is a multicentre clinical trial with medical device. As currently recommended by international neonatal resuscitation guidelines, the most reliable method to verify the correct positioning of the endotracheal tube, in association with clinical signs, is the end-tidal capnometry obtained either by infrared… Read more about this study
- Who is it for?
- Ages 20 minutes to 3 months
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- confirmation of endotracheal tube positioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2022to Jun 2023
- 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 20 minutes to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term and preterm infants requiring tracheal intubation within the neonatal intensive care unit, both in elective and emergency conditions.
Who cannot join
- intubation at birth
- intubation during cardiopulmonary resuscitation
- absence of informed consent by parents
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Paolo Biban, MD, paolo.biban@aovr.veneto.it
About this study
Official title: Comparison Between Flow Sensor and Colourimetric Capnometer in Verifying the Correct Positioning of the Endotracheal Tube in Term and Preterm Infants
This is a multicentre clinical trial with medical device. As currently recommended by international neonatal resuscitation guidelines, the most reliable method to verify the correct positioning of the endotracheal tube, in association with clinical signs, is the end-tidal capnometry obtained either by infrared spectroscopy or colorimetric method. The aim of the present study is to evaluate whether the flow sensor of a standard mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube after a tracheal intubation attempt compared to the colorimetric capnometer, in newborns undergoing this procedure during hospitalization in the neonatal intensive care unit.
Given the importance of defining a rapid and effective method to prevent possible adverse events of incorrect endotracheal intubation, this study aims to verify whether the ventilator flow sensor can allow a reliable assessment of the correct positioning of the endotracheal tube, with timing and success rates equivalent to or better than the colorimetric capnometer.
Read the detailed description
Specifically, the neonatologist performing the procedure will follow the standard procedure for tracheal intubation, which includes using a colourimetric capnometer to confirm the correct tube positioning. However, he/she will remain blind and not aware of the flow sensor signal, while a study investigator will monitor that.
The investigators will measure the percentage of responses of correct positioning of the endotracheal tube as well as the number of insufflations and the time elapsed before obtaining a signal of correct intubation by simultaneously comparing both methods and checking any differences based on the characteristics of the sample analyzed (e.g. premature infants versus term infants, elective versus emergency intubations).
- Conditions
- Tracheal Intubation
- Being tested
- confirmation of endotracheal tube positioning
- Keywords
- tracheal intubation, tracheal tube positioning, colorimetric capnometer, flow sensor, invasive mechanical ventilation, newborn, preterm infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
confirmation of endotracheal tube positioningDevice
After performing the tube insertion by direct laryngoscopy, videolaringoscopy or fiberoptic technique, the attending neonatologist will connect both the colorimetric capnometer and the proximal flow-sensor to the tracheal tube. If the flow sensor is not proximal but incorporated into the mechanical ventilator, the care provider will connect the capnometer only. During the procedure, the information given by the capnometer will be evaluated by the care provider performing the intubation, while the flow sensor information will be monitored only by a study investigator, who will not reveal any details to the care provider. In particular, the yellow color change by the capnometer and the presence of exhalation flow curves on the ventilator screen will be considered as confirmation of correct tracheal tube positioning, respectively.
| Study group | Role | What they receive |
|---|---|---|
| all patients undergoing tracheal intubation procedure | Other | In current practice, the endotracheal intubation procedure includes the systematic use of the capnometer, which is immediately connected to the tube after its insertion by direct laringoscopy. Confirmation of the correct tube positioning is established by color change of the capnometer from violet to yellow. Then, the colorimetric capnometer is usually removed before connecting the endotracheal tube to the flow-sensor of the ventilator.
For the purpose of our study, after the tube insertion the care provider will connect in line both the capnometer and the ventilator flow-sensor to the tracheal tube. Receives: Device: confirmation of endotracheal tube positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken by the flow-sensor to indicate the correct or not correct positioning of the tracheal tube, compared with time taken by the colorimetric capnometer.
To compare the time (expressed in seconds) taken by the flow sensor and the colorimetric capnometer, respectively, to indicate the correct or not correct positioning of the tube in newborns undergoing tracheal intubation procedure during neonatal intensive care unit admission.
The aim is to evaluate if the flow sensor of the mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube during the tracheal intubation procedure compared to the colorimetric capnometer.
Measured: Immediately after the tracheal intubation attempt
Number of mechanical breaths necessary to indicate the correct or not correct positioning of the tracheal tube by evaluating the flow-sensor curves and the color change of the colorimetric capnometer.
To compare the minimal number of mechanical breaths provided by the ventilator to indicate the correct or not correct positioning of the tube in newborns undergoing tracheal intubation procedure, either evaluating the flow-sensor curves and the color change of the colorimetric capnometer, respectively.
The aim is to evaluate if the flow sensor of the mechanical ventilator can indicate with lower or equal number of mechanical breaths the correct positioning of the tube during tracheal intubation compared to the colorimetric capnometer.
Measured: Immediately after the tracheal intubation attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start10 Feb 2022
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simultaneous assignment, as the two methods to confirm the endotracheal tube position, namely the colorimetric capnometer and the flow sensor signal, will be evaluated simultaneously in each recruited patient.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Biban, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162313
- Sponsor's protocol ID
- 2880CESC
- Acronym
- FlowNET
- Status last verified
- Mar 2022
- First submitted
- 6 Dec 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Flow Sensor and Colourimetric Capnometer in Verifying the Correct Positioning of the Endotracheal Tube in Term and Preterm Infants
- ClinicalTrials.gov ID
- NCT05162313
- Acronym / sponsor ID
- FlowNET / 2880CESC
- Conditions
- Tracheal Intubation
- Keywords
- tracheal intubation, tracheal tube positioning, colorimetric capnometer, flow sensor, invasive mechanical ventilation, newborn, preterm infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 17 Dec 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.
This is a multicentre clinical trial with medical device. As currently recommended by international neonatal resuscitation guidelines, the most reliable method to verify the correct positioning of the endotracheal tube, in association with clinical signs, is the end-tidal capnometry obtained either by infrared spectroscopy or colorimetric method. The aim of the present study is to evaluate whether the flow sensor of a standard mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube after a tracheal intubation attempt compared to the colorimetric capnometer, in newborns undergoing this procedure during hospitalization in the neonatal intensive care unit.
Given the importance of defining a rapid and effective method to prevent possible adverse events of incorrect endotracheal intubation, this study aims to verify whether the ventilator flow sensor can allow a reliable assessment of the correct positioning of the endotracheal tube, with timing and success rates equivalent to or better than the colorimetric capnometer.
Detailed description
Specifically, the neonatologist performing the procedure will follow the standard procedure for tracheal intubation, which includes using a colourimetric capnometer to confirm the correct tube positioning. However, he/she will remain blind and not aware of the flow sensor signal, while a study investigator will monitor that.
The investigators will measure the percentage of responses of correct positioning of the endotracheal tube as well as the number of insufflations and the time elapsed before obtaining a signal of correct intubation by simultaneously comparing both methods and checking any differences based on the characteristics of the sample analyzed (e.g. premature infants versus term infants, elective versus emergency intubations).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simultaneous assignment, as the two methods to confirm the endotracheal tube position, namely the colorimetric capnometer and the flow sensor signal, will be evaluated simultaneously in each recruited patient.
| Arm | Type | Receives |
|---|---|---|
| all patients undergoing tracheal intubation procedure | Other | Device: confirmation of endotracheal tube positioningIn current practice, the endotracheal intubation procedure includes the systematic use of the capnometer, which is immediately connected to the tube after its insertion by direct laringoscopy. Confirmation of the correct tube positioning is established by color change of the capnometer from violet to yellow. Then, the colorimetric capnometer is usually removed before connecting the endotracheal tube to the flow-sensor of the ventilator. For the purpose of our study, after the tube insertion the care provider will connect in line both the capnometer and the ventilator flow-sensor to the tracheal tube. |
Who may qualify
- Ages
- 20 minutes to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Term and preterm infants requiring tracheal intubation within the neonatal intensive care unit, both in elective and emergency conditions.
Key exclusion criteria (3 listed)
- intubation at birth
- intubation during cardiopulmonary resuscitation
- absence of informed consent by parents
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 |
|---|---|---|
| confirmation of endotracheal tube positioningAfter performing the tube insertion by direct laryngoscopy, videolaringoscopy or fiberoptic technique, the attending neonatologist will connect both the colorimetric capnometer and the proximal flow-sensor to the tracheal tube. If the flow sensor is not proximal but incorporated into the mechanical ventilator, the care provider will connect the capnometer only. During the procedure, the information given by the capnometer will be evaluated by the care provider performing the intubation, while the flow sensor information will be monitored only by a study investigator, who will not reveal any details to the care provider. In particular, the yellow color change by the capnometer and the presence of exhalation flow curves on the ventilator screen will be considered as confirmation of correct tracheal tube positioning, respectively. | Device | all patients undergoing tracheal intubation procedure |
Primary outcome
Time taken by the flow-sensor to indicate the correct or not correct positioning of the tracheal tube, compared with time taken by the colorimetric capnometer.
Time frame: Immediately after the tracheal intubation attempt
To compare the time (expressed in seconds) taken by the flow sensor and the colorimetric capnometer, respectively, to indicate the correct or not correct positioning of the tube in newborns undergoing tracheal intubation procedure during neonatal intensive care unit admission. The aim is to evaluate if the flow sensor of the mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube during the tracheal intubation procedure compared to the colorimetric capnometer.
Number of mechanical breaths necessary to indicate the correct or not correct positioning of the tracheal tube by evaluating the flow-sensor curves and the color change of the colorimetric capnometer.
Time frame: Immediately after the tracheal intubation attempt
To compare the minimal number of mechanical breaths provided by the ventilator to indicate the correct or not correct positioning of the tube in newborns undergoing tracheal intubation procedure, either evaluating the flow-sensor curves and the color change of the colorimetric capnometer, respectively. The aim is to evaluate if the flow sensor of the mechanical ventilator can indicate with lower or equal number of mechanical breaths the correct positioning of the tube during tracheal intubation compared to the colorimetric capnometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing confirmation of endotracheal tube positioning in people with Tracheal Intubation, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Biban, MD (+00390458122041, PAOLO.BIBAN@AOVR.VENETO.IT), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken by the flow-sensor to indicate the correct or not correct positioning of the tracheal tube, compared with time taken by the colorimetric capnometer. (time frame: Immediately after the tracheal intubation attempt). The study lists 2 primary outcomes in all. 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 8 Mar 2022.