Child
Conditions
Keywords
Oesophageal, Nasopharyngeal, temperature, Intubation, endotracheal, Pediatric, Anesthesia, Hypothermia
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.
Interventions
DEVICENasopharyngeal and oesophageal temperature probes
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Months to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%) | 6 months | Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements. |
Countries
United Kingdom
Participant flow
Pre-assignment details
9 were excluded due to incomplete data or insufficient FVL difference between cuff down and cuff up scenarios
Participants by arm
| Arm | Count |
|---|---|
| Cuff Inflation and Cuff Deflation Groups Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Cuff Inflation and Cuff Deflation Groups | — |
|---|---|---|
| Age, Continuous | 2.3 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 50 participants | — |
| Sex: Female, Male Female | 20 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 59 |
| serious Total, serious adverse events | 0 / 59 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cuff Inflation and Cuff Deflation Groups | 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 |
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.
Time frame: 6 months