N/A
Completed N=50
Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children
Child
Source: ClinicalTrials.gov NCT02201628 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx — 0.10 temperature difference degrees celsius
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx |
0.10 | — |
| SECONDARY Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%) |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02201628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.