Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children

Comparison of Nasopharyngeal and Lower Oesophageal Temperatures Under General Anaesthesia With an Endotracheal Tube With Leak

Sponsors

Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Source Great Ormond Street Hospital for Children NHS Foundation Trust
Brief Summary

Children lose heat under general anaesthesia, thus temperature is routinely monitored during anaesthesia for all but the shortest cases, and active warming can be used to prevent hypothermia and its resulting complications. Temperature can be measured at several sites dependent on the type of surgery and patient factors. Previously a temperature probe has been sited in the lower third of the oesophagus (swallowing tube) but it is difficult to accurately place this without an X-Ray. Consequently it is more common to use a temperature probe placed in the nasopharynx (where the nose and throat meet), when the child is anaesthetised.

However the investigators do not know if the temperature in the nasopharynx correlates well with the real core temperature or not.This prospective, unblinded, agreement study will seek to find an agreement of 2 methods to measure temperature in children undergoing general anaesthesia with a breathing tube that has a leak.

Detailed Description

It is known that temperature in the lower third of the oesophagus correlates well with the gold standard of core temperature measurement, namely the temperature of blood in the heart. It is not known if oesophageal and nasopharyngeal temperatures correlate in children on a breathing machine via a tube with leak. If this study were to find a good correlation between oesophageal and nasopharyngeal temperature, this would allow clinicians to confidently use the more feasible nasopharyngeal temperature probes.

For this study 100 children will have both nasopharyngeal and oesophageal temperatures measured during general anaesthesia, both in the presence and absence of a leak around the endotracheal tube.

It is hypothesised that even in the presence of a leak, the temperature difference between the two methods will be less than 0.5 degrees centigrade.

Overall Status Unknown status
Start Date July 2014
Completion Date April 2015
Primary Completion Date January 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Temperature difference (in degrees celsius) between 2 body sites in children undergoing general anaesthesia. The 2 sites are: (1) lower oesophagus; (2) nasopharynx 6 months
Secondary Outcome
Measure Time Frame
Temperature difference in the presence of a small leak (fractional volume loss < 21%) and large leak (fractional volume loss > 21%) 6 months
Enrollment 100
Condition
Intervention

Intervention Type: Device

Intervention Name: Nasopharyngeal and oesophageal temperature probes

Arm Group Label: Nasopharyngeal and oesophageal temperatures

Eligibility

Criteria:

Inclusion Criteria:

- Patient requires general anaesthesia with endotracheal intubation for a procedure assisted by radiography (e.g. line insertion, line change).

- Patient requires chest radiograph for procedure.

- Expected anaesthetic time more than 30 minutes.

Exclusion Criteria:

- No written parental written consent.

- Known oesophageal pathology (e.g. tracheo-oesophageal fistula, oesophageal strictures, oesophageal varices, oesophageal atresia).

- Known base of skull or midface fractures.

- Previous gastric bypass surgery or nasal surgery.

- Known coagulopathy.

- Previous alkaline ingestion.

- High aspiration risk.

- Significant respiratory co-morbidity requiring anticipated peak airway pressures > 25 cm of water

- American Society Anaesthesiologists (ASA) grading 4 - 5.

- Tracheostomy in situ.

- Severe sepsis or septic shock or other other condition (such as bronchopulmonary fistula) that precludes use of tidal volume ventilation over 7 ml/kg.

- Known airway abnormalities (e.g. subglottic stenosis) that preclude placement of a MicroCuff® endotracheal tube.

- Oesophageal or nasopharyngeal probe contraindicated for reasons related to surgery / procedure.

Gender: All

Minimum Age: 8 Months

Maximum Age: 7 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Emily Haberman, MBBS

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Great Ormond Street Hospital for Children NHS Foundation Trust Aarjan Snoek, MBChB, FRCA 0207 405 9200 1389 [email protected] Helen V Hume-Smith, MBBS, FRCA Principal Investigator Aarjan P Snoek, MBChB, FRCA Principal Investigator Emily Haberman, MBBS Principal Investigator
Location Countries

United Kingdom

Verification Date

July 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Nasopharyngeal and oesophageal temperatures

Type: Experimental

Description: An oesophageal and nasopharyngeal temperature probe will be placed and temperature will be measured at these site

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov