Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study

NCT02042625 | Completed

• 1 other identifier: 13-1443
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 The nasopharyngeal probe will then be withdrawn 2 cm and after a 3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be recorded.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

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (1)

• insertion depth of nasopharyngeal probe for core temperature

  during surgery

Study Arms (1)

nasopharyngeal

OTHER

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 The nasopharyngeal probe will then be withdrawn 2 cm and after a 3-minute equilibration period, nasopharyngeal temperatures will again be recorded.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

Interventions

Nasopharyngeal PROCEDURE

nasopharyngeal

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mi Wang

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: January 23, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

US (1)