Accuracy of Nasopharyngeal ProbesNCT02993003
Optimal Positioning of Nasopharyngeal Temperature Probes
A study testing Nasopharyngeal probe in people with Accuracy of Nasopharyngeal Probes, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Core temperature is of greatest interest in terms of temperature monitoring as it is thought to represent the temperature of the vessel-rich groups that are instrumental in thermoregulatory control. The nasopharynx is among the recommended temperature monitoring sites for core body temperature. Read more about this study
- Who is it for?
- Ages 7 months to 12 years
- Conditions the study is for
- Accuracy of Nasopharyngeal Probes
- What is being tested?
- Nasopharyngeal probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2017
- 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 7 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective non-cardiac surgery in children to last at least 1.5 hours;
- Supine position anticipated;
- General endotracheal anesthesia.
Who cannot join
- Nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned oral or facial surgery;
- History of genetic or congenital anomalies leading to facial dimorphism;
- History of recent substantive epistaxis or suspected bleeding disorder;
- Therapeutic-dose anti-coagulation;
- Contraindication to esophageal temperature probe insertion (i.e., esophageal varices, congenital anomalies).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Positioning of Nasopharyngeal Temperature Probes in Pediatric Patients: A Prospective Cohort Study
Core temperature is of greatest interest in terms of temperature monitoring as it is thought to represent the temperature of the vessel-rich groups that are instrumental in thermoregulatory control. The nasopharynx is among the recommended temperature monitoring sites for core body temperature. It is the part of the pharynx that lies above the soft palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures are accurate in adults when probes are inserted between 10 and 20 cm.
The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants and children. While some data suggest that anthropometric measurements are well correlated with endoscopic measurements in infants based on weight, the accuracy of temperature measurements at these and other distances has yet to be quantified. The investigators thus propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature proves that best approximate core temperature as measured in the distal esophagus in infants and children of various sizes. The comparison site will be the distal esophagus since there is broad consensus that the distal third of the esophagus it at core-body temperature.
Read more
For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm.
Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated increment for each age group and will be equilibrated for 5 minutes before the temperature is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of measurement will depend on the initial depth of insertion, with measurements continuing until only 2 centimeters remain in the nostril.
- Conditions
- Accuracy of Nasopharyngeal Probes
- Being tested
- Nasopharyngeal probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal probeDevice
nasopharyngeal probe insertion
| Study group | Role | What they receive |
|---|---|---|
| Children between 7 months and 12 months | Other | nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm Receives: Device: Nasopharyngeal probe |
| children between 1 and 5 years | Other | nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm Receives: Device: Nasopharyngeal probe |
| children between 6 and 12 years | Other | a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm Receives: Device: Nasopharyngeal probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasopharyngeal and esophageal temperatures
nasopharyngeal and esophageal temperatures at each depth
Measured: up to 2 hrs during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy of Nasopharyngeal ProbesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Sessler, M.D., Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993003
- Sponsor's protocol ID
- 15-1216
- Status last verified
- Jan 2018
- First submitted
- 18 Jul 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Positioning of Nasopharyngeal Temperature Probes in Pediatric Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02993003
- Acronym / sponsor ID
- 15-1216
- Conditions
- Accuracy of Nasopharyngeal Probes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 14 Dec 2016 (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.
Core temperature is of greatest interest in terms of temperature monitoring as it is thought to represent the temperature of the vessel-rich groups that are instrumental in thermoregulatory control. The nasopharynx is among the recommended temperature monitoring sites for core body temperature. It is the part of the pharynx that lies above the soft palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures are accurate in adults when probes are inserted between 10 and 20 cm.
The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants and children. While some data suggest that anthropometric measurements are well correlated with endoscopic measurements in infants based on weight, the accuracy of temperature measurements at these and other distances has yet to be quantified. The investigators thus propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature proves that best approximate core temperature as measured in the distal esophagus in infants and children of various sizes. The comparison site will be the distal esophagus since there is broad consensus that the distal third of the esophagus it at core-body temperature.
For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm.
Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated increment for each age group and will be equilibrated for 5 minutes before the temperature is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of measurement will depend on the initial depth of insertion, with measurements continuing until only 2 centimeters remain in the nostril.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children between 7 months and 12 months | Other | Device: Nasopharyngeal probenasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm |
| children between 1 and 5 years | Other | Device: Nasopharyngeal probenasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm |
| children between 6 and 12 years | Other | Device: Nasopharyngeal probea nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm |
Who may qualify
- Ages
- 7 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Elective non-cardiac surgery in children to last at least 1.5 hours;
- Supine position anticipated;
- General endotracheal anesthesia.
Key exclusion criteria (5 listed)
- Nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned oral or facial surgery;
- History of genetic or congenital anomalies leading to facial dimorphism;
- History of recent substantive epistaxis or suspected bleeding disorder;
- Therapeutic-dose anti-coagulation;
- Contraindication to esophageal temperature probe insertion (i.e., esophageal varices, congenital anomalies).
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 |
|---|---|---|
| Nasopharyngeal probenasopharyngeal probe insertion | Device | Children between 7 months and 12 months, children between 1 and 5 years, children between 6 and 12 years |
Primary outcome
nasopharyngeal and esophageal temperatures
Time frame: up to 2 hrs during surgery
nasopharyngeal and esophageal temperatures at each depth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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.
Daniel Sessler, M.D. study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal probe in people with Accuracy of Nasopharyngeal Probes, run by The Cleveland Clinic 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 Jan 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 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 withdrawn before enrolling participants, so there are no results.
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?
nasopharyngeal and esophageal temperatures (time frame: up to 2 hrs during surgery). 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 2018.