Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study

July 18, 2016 updated by: The Cleveland Clinic

Low body temperature (hypothermia) is often observed in anesthetized patients. Mild hypothermia increases complications such as surgical blood loss, postanesthesia recovery and the duration of hospitalization. To assess body temperature and minimize hypothermia-related complications, it is important to have accurate and reliable methods of measuring intraoperative core temperature. Common practice is to insert a nasopharyngeal (back of the throat from the nose) probe through one of the nostrils. However, there is no consensus or guideline regarding how deep the nasopharyngeal probe needs to be inserted. This study is being done to determine the insertion depth (or range of depths) that best approximates core temperature, which is temperature of the vital organs, e.g. heart, liver and lungs.

Participation in the trial will occur on the day of surgery. The subject will be asked to breathe through one nostril and then the other before receiving anesthesia. The less congested nostril will be selected for study. If there is no difference, then the investigator will use the right nostril.

Once under anesthesia, an esophageal temperature probe will be inserted to serve as a reference core temperature, which is used routinely in surgery. Then the nasopharyngeal probe will be inserted into the nostril.

Both nasopharyngeal and esophageal temperatures will initially be recorded 45 minutes after anesthetic induction. The nasopharyngeal probe will then be withdrawn 2 cm and after a 3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be recorded. The nasopharyngeal probe withdrawal sequence will be repeated, 2 cm at a time, until only 2 cm remains in the nostril. There will be a total of 10 sets of nasopharyngeal and esophageal temperatures obtained.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective non-cardiac surgery scheduled to last at least 1.5 hours
  • supine position anticipated
  • general anesthesia with ETT

Exclusion Criteria:

  • nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned surgery in the region
  • history of recent substantive epistaxis
  • history of bleeding disorders
  • therapeutic-dose anti-coagulation (aspirin and DVT prophylaxis permitted)
  • contraindications to esophageal temperature probe insertion (e.g. known varices)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: nasopharyngeal
The nasopharyngeal probe will be inserted into the nostril. The nasopharyngeal temperature will initially be recorded 45 minutes after anesthetic induction. The nasopharyngeal probe will then be withdrawn 2 cm and after a 3-minute equilibration period, nasopharyngeal temperatures will again be recorded. The nasopharyngeal probe withdrawal sequence will be repeated, 2 cm at a time, until only 2 cm remains in the nostril. There will be a total of 10 sets of nasopharyngeal temperatures obtained.
Procedure: Nasopharyngeal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insertion depth of nasopharyngeal probe for core temperature
Time Frame: during surgery
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Mi Wang, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

January 20, 2014

First Posted (ESTIMATE)

January 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1443

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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