Pediatric TemperatureNCT02963285
Optimal Positioning of Nasopharyngeal Temp Probe
An observational study of Pediatric Temperature, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal range of insertion depths for a nasopharyngeal probe in anesthetized pediatric patients as a function of age. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Pediatric Temperature
- What is being tested?
- Nasopharyngeal temperature probe
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 3 Aug 2021
- 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 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: The subjects will be pediatric patients having elective non-cardiac surgery with general anesthesia and endotracheal intubation at the Children's Health.
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.
United States1 site
Children's Health Children's Medical Center Dallas
Dallas, Texas, 75235
About this study
Official title: Optimal Positioning of Nasopharyngeal Temperature Probes in Pediatric Patients: A Prospective Cohort Study
The purpose of this study is to determine the optimal range of insertion depths for a nasopharyngeal probe in anesthetized pediatric patients as a function of age.
Read the detailed description
Before surgery, the esophageal and nasopharyngeal probes (DeRoyal GP/Nasopharyngeal Probe, 9F, 400 series [REF 81-025409] to be used in a given patient will be connected to the two channels of the clinical monitor in the designated room. The tips will be inserted at least five centimeters into a well stirred container of water maintained near 370 Celsius. Temperatures will be recorded from each, and the offset (if any) used as a correction factor in the statistical analysis below.
After anesthetic induction and intubation, patients will be positioned per clinical routine for the selected operation. An esophageal temperature probe (DeRoyal General Purpose Temperature Probe, SOFT 9 French, 400 series [REF V81-010400]) will be inserted. The optimal placement of the esophageal temperature probe varies based on the height of the patient8. Broad consensus is that the measurement is most accurate in the distal third of the esophagus. The use of acoustic criteria for optimal placement is not a reliable method9. Bloch et al.,5 proposed the use of a simple formula of one quarter of the patient's height plus 4.5 centimeters with the upper incisors as the starting point. This technique reliably locates the tip of the probe 2 centimeters above the lower esophageal sphincter.
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 15 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. In each case, investigators will confirm under direct vision that the probe tip is visible in the oropharynx. Insertion will be repeated if necessary; the contralateral nostril or a new probe can be used.
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 3 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.
Temperature in the operating room will be maintained per clinical routine. Normothermia will be maintained with forced-air warmer and if necessary with overhead warming lights per clinical routine.
- Conditions
- Pediatric Temperature
- Being tested
- Nasopharyngeal temperature probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal temperature probeOther
Nasopharyngeal 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 3 minutes before the temperature is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| 0 to 6 months | Not described Receives: Other: Nasopharyngeal temperature probe | |
| 7 months to less than 1 year | Not described Receives: Other: Nasopharyngeal temperature probe | |
| 1 to less than 2 years | Not described Receives: Other: Nasopharyngeal temperature probe | |
| 2 to less than 6 years | Not described Receives: Other: Nasopharyngeal temperature probe | |
| 6 to 12 years | Not described Receives: Other: Nasopharyngeal temperature probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between esophageal temp and nasopharyngeal temp
Nasopharyngeal probe will be withdrawn incrementally, with 5 minutes to equilibrate at each depth.
Measured: 5 minute increments at each position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start9 Jun 2017
- Primary completion2 Dec 2020
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric TemperatureStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Zhong, University of Texas Southwestern Medical Center
- Investigators
- John Zhong, MD, Principal investigator, UTSouthwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963285
- Sponsor's protocol ID
- STU 072016-059
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 2016
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. 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
- NCT02963285
- Acronym / sponsor ID
- STU 072016-059
- Conditions
- Pediatric Temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 15 Nov 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.
The purpose of this study is to determine the optimal range of insertion depths for a nasopharyngeal probe in anesthetized pediatric patients as a function of age.
Detailed description
Before surgery, the esophageal and nasopharyngeal probes (DeRoyal GP/Nasopharyngeal Probe, 9F, 400 series [REF 81-025409] to be used in a given patient will be connected to the two channels of the clinical monitor in the designated room. The tips will be inserted at least five centimeters into a well stirred container of water maintained near 370 Celsius. Temperatures will be recorded from each, and the offset (if any) used as a correction factor in the statistical analysis below.
After anesthetic induction and intubation, patients will be positioned per clinical routine for the selected operation. An esophageal temperature probe (DeRoyal General Purpose Temperature Probe, SOFT 9 French, 400 series [REF V81-010400]) will be inserted. The optimal placement of the esophageal temperature probe varies based on the height of the patient8. Broad consensus is that the measurement is most accurate in the distal third of the esophagus. The use of acoustic criteria for optimal placement is not a reliable method9. Bloch et al.,5 proposed the use of a simple formula of one quarter of the patient's height plus 4.5 centimeters with the upper incisors as the starting point. This technique reliably locates the tip of the probe 2 centimeters above the lower esophageal sphincter.
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 15 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. In each case, investigators will confirm under direct vision that the probe tip is visible in the oropharynx. Insertion will be repeated if necessary; the contralateral nostril or a new probe can be used.
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 3 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.
Temperature in the operating room will be maintained per clinical routine. Normothermia will be maintained with forced-air warmer and if necessary with overhead warming lights per clinical routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0 to 6 months | – | Other: Nasopharyngeal temperature probe |
| 7 months to less than 1 year | – | Other: Nasopharyngeal temperature probe |
| 1 to less than 2 years | – | Other: Nasopharyngeal temperature probe |
| 2 to less than 6 years | – | Other: Nasopharyngeal temperature probe |
| 6 to 12 years | – | Other: Nasopharyngeal temperature probe |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The subjects will be pediatric patients having elective non-cardiac surgery with general anesthesia and endotracheal intubation at the Children's Health.
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 temperature probeNasopharyngeal 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 3 minutes before the temperature is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. | Other | 0 to 6 months, 1 to less than 2 years, 2 to less than 6 years, 6 to 12 years, 7 months to less than 1 year |
Primary outcome
Difference between esophageal temp and nasopharyngeal temp
Time frame: 5 minute increments at each position
Nasopharyngeal probe will be withdrawn incrementally, with 5 minutes to equilibrate at each depth.
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 Jan 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.
John Zhong, MD principal investigator
UTSouthwestern Medical Center
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 Pediatric Temperature, run by University of Texas Southwestern Medical Center 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: finished, as of the sponsor's last update on 6 Jan 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 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 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?
Difference between esophageal temp and nasopharyngeal temp (time frame: 5 minute increments at each position). 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 Jan 2022.