Nasopharyngeal Airway PressureNCT00766194
Nasopharyngeal Pressure Measurement During Neonatal Nasal Respiratory Support
An observational study of Nasopharyngeal Airway Pressure, run by University of Utah at 1 site in United States.
Trial summary
This study will measure nasopharyngeal pressure in neonates using a miniature high resolution catheter-tip pressure transducer. Any neonatal intensive care patient being treated with nasal respiratory support (e.g., nasal continuous positive airway pressure, nasal cannula flow either high (>1 LPM) or low (<1 LPM), and… Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Nasopharyngeal Airway Pressure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2012
- 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: Any infant admitted to neonatal intensive care who is treated with a modality of non-invasive respiratory support, such as low or high flow nasal cannula; nasal prong, catheter or mask continuous distending pressure; or nasal ventilation either intermittent mandatory, synchronized or high frequency will be eligible for study.
Who may be able to join
- Any infant admitted to neonatal intensive care who is treated with a modality of non-invasive respiratory support, such as low or high flow nasal cannula; nasal prong, catheter or mask continuous distending pressure; or nasal ventilation either intermittent mandatory, synchronized or high frequency will be eligible for study.
Who cannot join
- Patients with oral, nasal, or palatal deformities who can not otherwise be fitted with cannula or mask will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, 84132
About this study
This study will measure nasopharyngeal pressure in neonates using a miniature high resolution catheter-tip pressure transducer. Any neonatal intensive care patient being treated with nasal respiratory support (e.g., nasal continuous positive airway pressure, nasal cannula flow either high (>1 LPM) or low (<1 LPM), and nasal prong ventilation either intermittent mandatory or high-frequency) will be eligible for study. The catheter-tip transducer will be placed within a standard gavage feeding tube catheter and introduced through the mouth into the posterior nasopharynx where continuous measurements will be made over 15 minutes. The 15 minute recording will be divided into 5 three minute segments, including a baseline recording at the ordered settings of pressure or flow, a recording at 1 level above baseline, a recording back at baseline, a recording 1 level below baseline, and a final segment back at baseline. The order of increase-decrease or decrease-increase from baseline will be by random sequence. Measurements may be repeated with any change in nasal gas flow or pressure ordered for patient care. These measurements will be used to correlate the ordered nasal respiratory support therapy with the actual upper airway pressure created by the therapy.
Read the detailed description
Non-invasive respiratory treatments are being used more frequently during neonatal intensive care. High-flow nasal cannula,1-2 nasal continuous positive airway pressure,3 nasal intermittent mandatory or synchronized ventilation,4 and high-frequency nasal continuous airway pressure5-6 are some of these modalities. These non-invasive therapies attempt to provide adequate oxygen delivery, positive end-expiratory pressure to maintain lung recruitment, and ventilation assistance without the need for endotracheal intubation. The benefits may be substantial, including decreased frequency of nosocomial infection, decreased risk for lung injury, and prevention of arrest in pulmonary development for those very preterm infants with immature lungs. However, there are very few reports of actual measurement of nasopharyngeal pressure during use of these non-invasive therapies.1,7 Combined, only 27 patients are included in two studies. Only one modality, high-flow nasal cannula, was evaluated. One study in 11 patients suggests a 2-3 cmH2O pressure drop exists between applied and delivered airway pressure.7 In order to better understand the relationship between applied and delivered airway pressures with all types of non-invasive therapy, we propose to measure nasopharyngeal pressure in neonates being treated with these modes of respiratory support.
If non-invasive respiratory support is initiated as part of routine pulmonary therapy for a neonate admitted to neonatal intensive care, the infant will be considered eligible for study if no exclusion criteria are met. Informed consent/parental permission will be requested and if obtained, the infant will be included for study.
The study procedure will be as follows:
- Care information will be documented, to include the infant's post-menstrual and post-delivery age, current weight, current level of supplemental oxygen administration, current pulse oximeter saturation level, applied flow and pressure settings, and if non-invasive ventilation is being used, the ventilator parameters.
- A high resolution fiber optic pressure tip transducer catheter will be inserted into a 5F or similar size fenestrated tube (such as an Anderson catheter) and introduced through the mouth towards the posterior pharynx. The pressure transducer/catheter combination will only be inserted the minimum distance to obtain a stable pressure signal reading and not produce choking or gagging in the infant. If the infant demonstrates choking or gagging, the tube will be withdrawn to a position that does not produce choking or gagging in the infant. If the pressure signal suggests that the catheter openings may be occluded with mucous, 5mL of air may be injected into the catheter to clear the mucous and obtain a satisfactory recording.
- A 1 to 5 minute recording will be made from the pressure transducer onto a notebook computer at the current non-invasive therapy settings.
- Two more 1 to 5 minute recordings will be made, either 0.5-1.0 cmH2O or 0.5-1.0 liter per minute flow (depending on the non-invasive modality) above and below the current settings. The order of the increase or decrease will be by random sequence.
- A final fourth 1 to 5 minute recording will be made when the settings have been returned to the current baseline settings.
- Pulse oximeter saturation will be recorded both before and after each recording.
- A study infant will undergo a baseline study procedure, and re-studied whenever the non-invasive therapy settings are changed based on clinical management.
- Conditions
- Nasopharyngeal Airway Pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Airway PressureStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Investigators
- Donald .Null, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766194
- Sponsor's protocol ID
- 22939/36001
- Status last verified
- Sep 2013
- First submitted
- 3 Sep 2008
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasopharyngeal Pressure Measurement During Neonatal Nasal Respiratory Support
- ClinicalTrials.gov ID
- NCT00766194
- Acronym / sponsor ID
- 22939/36001
- Conditions
- Nasopharyngeal Airway Pressure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Oct 2008 (estimated)
- 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 study will measure nasopharyngeal pressure in neonates using a miniature high resolution catheter-tip pressure transducer. Any neonatal intensive care patient being treated with nasal respiratory support (e.g., nasal continuous positive airway pressure, nasal cannula flow either high (>1 LPM) or low (<1 LPM), and nasal prong ventilation either intermittent mandatory or high-frequency) will be eligible for study. The catheter-tip transducer will be placed within a standard gavage feeding tube catheter and introduced through the mouth into the posterior nasopharynx where continuous measurements will be made over 15 minutes. The 15 minute recording will be divided into 5 three minute segments, including a baseline recording at the ordered settings of pressure or flow, a recording at 1 level above baseline, a recording back at baseline, a recording 1 level below baseline, and a final segment back at baseline. The order of increase-decrease or decrease-increase from baseline will be by random sequence. Measurements may be repeated with any change in nasal gas flow or pressure ordered for patient care. These measurements will be used to correlate the ordered nasal respiratory support therapy with the actual upper airway pressure created by the therapy.
Detailed description
Non-invasive respiratory treatments are being used more frequently during neonatal intensive care. High-flow nasal cannula,1-2 nasal continuous positive airway pressure,3 nasal intermittent mandatory or synchronized ventilation,4 and high-frequency nasal continuous airway pressure5-6 are some of these modalities. These non-invasive therapies attempt to provide adequate oxygen delivery, positive end-expiratory pressure to maintain lung recruitment, and ventilation assistance without the need for endotracheal intubation. The benefits may be substantial, including decreased frequency of nosocomial infection, decreased risk for lung injury, and prevention of arrest in pulmonary development for those very preterm infants with immature lungs. However, there are very few reports of actual measurement of nasopharyngeal pressure during use of these non-invasive therapies.1,7 Combined, only 27 patients are included in two studies. Only one modality, high-flow nasal cannula, was evaluated. One study in 11 patients suggests a 2-3 cmH2O pressure drop exists between applied and delivered airway pressure.7 In order to better understand the relationship between applied and delivered airway pressures with all types of non-invasive therapy, we propose to measure nasopharyngeal pressure in neonates being treated with these modes of respiratory support.
If non-invasive respiratory support is initiated as part of routine pulmonary therapy for a neonate admitted to neonatal intensive care, the infant will be considered eligible for study if no exclusion criteria are met. Informed consent/parental permission will be requested and if obtained, the infant will be included for study.
The study procedure will be as follows:
- Care information will be documented, to include the infant's post-menstrual and post-delivery age, current weight, current level of supplemental oxygen administration, current pulse oximeter saturation level, applied flow and pressure settings, and if non-invasive ventilation is being used, the ventilator parameters.
- A high resolution fiber optic pressure tip transducer catheter will be inserted into a 5F or similar size fenestrated tube (such as an Anderson catheter) and introduced through the mouth towards the posterior pharynx. The pressure transducer/catheter combination will only be inserted the minimum distance to obtain a stable pressure signal reading and not produce choking or gagging in the infant. If the infant demonstrates choking or gagging, the tube will be withdrawn to a position that does not produce choking or gagging in the infant. If the pressure signal suggests that the catheter openings may be occluded with mucous, 5mL of air may be injected into the catheter to clear the mucous and obtain a satisfactory recording.
- A 1 to 5 minute recording will be made from the pressure transducer onto a notebook computer at the current non-invasive therapy settings.
- Two more 1 to 5 minute recordings will be made, either 0.5-1.0 cmH2O or 0.5-1.0 liter per minute flow (depending on the non-invasive modality) above and below the current settings. The order of the increase or decrease will be by random sequence.
- A final fourth 1 to 5 minute recording will be made when the settings have been returned to the current baseline settings.
- Pulse oximeter saturation will be recorded both before and after each recording.
- A study infant will undergo a baseline study procedure, and re-studied whenever the non-invasive therapy settings are changed based on clinical management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any infant admitted to neonatal intensive care who is treated with a modality of non-invasive respiratory support, such as low or high flow nasal cannula; nasal prong, catheter or mask continuous distending pressure; or nasal ventilation either intermittent mandatory, synchronized or high frequency will be eligible for study.
Key inclusion criteria (1 listed)
- Any infant admitted to neonatal intensive care who is treated with a modality of non-invasive respiratory support, such as low or high flow nasal cannula; nasal prong, catheter or mask continuous distending pressure; or nasal ventilation either intermittent mandatory, synchronized or high frequency will be eligible for study.
Key exclusion criteria (1 listed)
- Patients with oral, nasal, or palatal deformities who can not otherwise be fitted with cannula or mask will be excluded from the study.
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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.
Donald .Null, M.D. principal investigator
University of Utah
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 Nasopharyngeal Airway Pressure, run by University of Utah at 1 site in United States.
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 1 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 12 Sep 2013. 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 United States. 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: slow enrollment). 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.
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 12 Sep 2013; AzTrials last refreshed its copy on 8 Nov 2026.