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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201628
• Other study ID #: 14SG04
• Status: Completed
• Phase: N/A
• Start date: June 25, 2014
• Est. completion date: December 16, 2014

Study information

• Verified date: April 2022
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 16, 2014
• Est. primary completion date: December 16, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Months to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child

Intervention

Device:
• Nasopharyngeal and oesophageal temperature probes

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (1)

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

Country where clinical trial is conducted

United Kingdom, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%)	Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.	6 months

External Links

•   Kimberly-Clark. Important MicroCuff® Paediatric Endotracheal Tube Points to Remember
•   National Institute for Health and Clinical Excellence. The management of inadvertent perioperative hypothermia in adults: full guideline