Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02042625
Collaborator
(none)
36
1
1
18
2

Study Details

Study Description

Brief Summary

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 The nasopharyngeal probe will then be withdrawn 2 cm and after a 3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be recorded.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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nasopharyngeal
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. insertion depth of nasopharyngeal probe for core temperature [during surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Principal Investigator: Mi Wang, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02042625
Other Study ID Numbers:
  • 13-1443
First Posted:
Jan 23, 2014
Last Update Posted:
Jul 20, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2016