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

NCT02201628 | Completed Results DMC

• 1 other identifier: 14SG04
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Child

Keywords

Oesophageal; Nasopharyngeal; temperature; Intubation, endotracheal; Pediatric; Anesthesia; Hypothermia

Outcome Measures

Primary Outcomes (1)

• Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx

  Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx. This will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.

  6 months

Secondary Outcomes (1)

• Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%)

  6 months

Study Arms (1)

Nasopharyngeal and oesophageal temperatures

EXPERIMENTAL

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

Device: Nasopharyngeal and oesophageal temperature probes

Interventions

Nasopharyngeal and oesophageal temperature probes DEVICE

Also known as: Covidien, Mon-a-therm™ General Purpose Temperature Probe 400TM, 90050

Nasopharyngeal and oesophageal temperatures

Eligibility Criteria

• Age: 8 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

Related Publications (29)

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• Whitby JD, Dunkin LJ. Temperature differences in the oesophagus. The effects of intubation and ventilation. Br J Anaesth. 1969 Jul;41(7):615-8. doi: 10.1093/bja/41.7.615. No abstract available.

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  PMID: 19887533 RESULT

Related Links

• National Institute for Health and Clinical Excellence. The management of inadvertent perioperative hypothermia in adults: full guideline

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Emily Haberman
• Organization: King's College Hospital NHS Foundation Trust

emilysaffer@gmail.com

07890549924

Study Officials

• Aarjan P Snoek, MBChB, FRCA

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Helen V Hume-Smith, MBBS, FRCA

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Emily Haberman, MBBS, FRCA

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 28, 2014
• Study Start: June 25, 2014
• Primary Completion: December 16, 2014
• Study Completion: December 16, 2014
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2022-04

Locations

GB (1)