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Optimal Positioning of Nasopharyngeal Temp Probe

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ClinicalTrials.gov Identifier: NCT02963285
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
John Zhong, University of Texas Southwestern Medical Center

Brief 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.

Condition or disease Intervention/treatment
Pediatric Temperature Other: Nasopharyngeal temperature probe

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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimal Positioning of Nasopharyngeal Temperature Probes in Pediatric Patients: A Prospective Cohort Study
Actual Study Start Date : June 9, 2017
Actual Primary Completion Date : December 2, 2020
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
0 to 6 months Other: Nasopharyngeal temperature probe
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.

7 months to less than 1 year Other: Nasopharyngeal temperature probe
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.

1 to less than 2 years Other: Nasopharyngeal temperature probe
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.

2 to less than 6 years Other: Nasopharyngeal temperature probe
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.

6 to 12 years Other: Nasopharyngeal temperature probe
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects will be pediatric patients having elective non-cardiac surgery with general anesthesia and endotracheal intubation at the Children's Health.
Criteria

Inclusion Criteria:

  1. Elective non-cardiac surgery in children to last at least 1.5 hours;
  2. Supine position anticipated;
  3. General endotracheal anesthesia.

Exclusion Criteria:

  1. Nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned oral or facial surgery;
  2. History of genetic or congenital anomalies leading to facial dimorphism;
  3. History of recent substantive epistaxis or suspected bleeding disorder;
  4. Therapeutic-dose anti-coagulation;
  5. Contraindication to esophageal temperature probe insertion (i.e., esophageal varices, congenital anomalies).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963285


Contacts
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Contact: John Zhong, MD 214-456-6393 john.zhong@childrens.com
Contact: Jordan Schutt, BS 214-456-8981 jordan.schutt@utsouthwestern.edu

Locations
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United States, Texas
Children's Health Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Jordan Schutt    214-456-8981    jordan.schutt@utsouthwestern.edu   
Principal Investigator: John Zhong, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: John Zhong, MD UTSouthwestern Medical Center
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Responsible Party: John Zhong, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02963285    
Other Study ID Numbers: STU 072016-059
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020