ChildNCT02201628

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

A study testing Nasopharyngeal and oesophageal temperature probes in people with Child, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 8 months to 7 years
Conditions the study is for: Child
What is being tested?: Nasopharyngeal and oesophageal temperature probes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUnited Kingdom
Study dates: 25 Jun 2014to 16 Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 months to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Conditions: Child
Being tested: Nasopharyngeal and oesophageal temperature probes
Keywords: Oesophageal, Nasopharyngeal, temperature, Intubation, endotracheal, Pediatric, Anesthesia, Hypothermia
Medical subject headings: Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nasopharyngeal and oesophageal temperature probesDevice
Also called Covidien, Mon-a-therm™ General Purpose Temperature Probe 400TM, 90050

Study groups in NCT02201628
Study group	Role	What they receive
Nasopharyngeal and oesophageal temperatures	Experimental	An oesophageal and nasopharyngeal temperature probe will be placed and temperature will be measured at these site Receives: Device: Nasopharyngeal and oesophageal temperature probes

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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%)
Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jun 201416 Dec 2014

First posted28 Jul 2014 (estimated)
Study start25 Jun 2014
Primary completion16 Dec 2014
Study completion16 Dec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (29)Papers the sponsor has linked to this study.
Other trials for ChildStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02201628
Sponsor's protocol ID: 14SG04
Status last verified: Apr 2022
First submitted: 15 Jul 2014
Last updated: 26 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
PubMed 19137809
Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.
PubMed 11506130
Evans DC, Doraiswamy VA, Prosciak MP, Silviera M, Seamon MJ, Rodriguez Funes V, Cipolla J, Wang CF, Kavuturu S, Torigian DA, Cook CH, Lindsey DE, Steinberg SM, Stawicki SP. Complications associated with pulmonary artery catheters: a comprehensive clinical review. Scand J Surg. 2009;98(4):199-208. doi: 10.1177/145749690909800402.
PubMed 20218415
Robinson JL, Seal RF, Spady DW, Joffres MR. Comparison of esophageal, rectal, axillary, bladder, tympanic, and pulmonary artery temperatures in children. J Pediatr. 1998 Oct;133(4):553-6. doi: 10.1016/s0022-3476(98)70067-8.
PubMed 9787697
SEVERINGHAUS JW, STUPFEL M. Internal body temperature gradients during anesthesia and hypothermia and effect of vagotomy. J Appl Physiol. 1956 Nov;9(3):380-6. doi: 10.1152/jappl.1956.9.3.380. No abstract available.
PubMed 13376459
Whitby JD, Dunkin LJ. Temperature differences in the oesophagus. Preliminary study. Br J Anaesth. 1968 Dec;40(12):991-5. doi: 10.1093/bja/40.12.991. No abstract available.
PubMed 5710916
Whitby JD, Dunkin LJ. Oesophageal temperature differences in children. Br J Anaesth. 1970 Nov;42(11):1013-5. doi: 10.1093/bja/42.11.1013. No abstract available.
PubMed 5488350
Kaukuntla H, Harrington D, Bilkoo I, Clutton-Brock T, Jones T, Bonser RS. Temperature monitoring during cardiopulmonary bypass--do we undercool or overheat the brain? Eur J Cardiothorac Surg. 2004 Sep;26(3):580-5. doi: 10.1016/j.ejcts.2004.05.004.
PubMed 15302054
Holtzclaw BJ. Monitoring body temperature. AACN Clin Issues Crit Care Nurs. 1993 Feb;4(1):44-55.
PubMed 8452743
Stone JG, Young WL, Smith CR, Solomon RA, Wald A, Ostapkovich N, Shrebnick DB. Do standard monitoring sites reflect true brain temperature when profound hypothermia is rapidly induced and reversed? Anesthesiology. 1995 Feb;82(2):344-51. doi: 10.1097/00000542-199502000-00004.
PubMed 7856892
Maxton FJ, Justin L, Gillies D. Estimating core temperature in infants and children after cardiac surgery: a comparison of six methods. J Adv Nurs. 2004 Jan;45(2):214-22. doi: 10.1046/j.1365-2648.2003.02883.x.
PubMed 14706007
Whitby JD, Dunkin LJ. Cerebral, oesophageal and nasopharyngeal temperatures. Br J Anaesth. 1971 Jul;43(7):673-6. doi: 10.1093/bja/43.7.673. No abstract available.
PubMed 5564234
Litman RS, Maxwell LG. Cuffed versus uncuffed endotracheal tubes in pediatric anesthesia: the debate should finally end. Anesthesiology. 2013 Mar;118(3):500-1. doi: 10.1097/ALN.0b013e318282cc8f. No abstract available.
PubMed 23314108
Strobel CT, Byrne WJ, Ament ME, Euler AR. Correlation of esophageal lengths in children with height: application to the Tuttle test without prior esophageal manometry. J Pediatr. 1979 Jan;94(1):81-4. doi: 10.1016/s0022-3476(79)80361-3. No abstract available.
PubMed 758430
Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
PubMed 18648241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Nasopharyngeal and Lower Oesophageal Temperatures Under General Anaesthesia With an Endotracheal Tube With Leak
ClinicalTrials.gov ID: NCT02201628
Acronym / sponsor ID: 14SG04
Conditions: Child
Keywords: Oesophageal, Nasopharyngeal, temperature, Intubation, endotracheal, Pediatric, Anesthesia, Hypothermia
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
Study start: 25 Jun 2014 (actual)
Primary completion: 16 Dec 2014 (actual)
Study completion: 16 Dec 2014 (actual)
First posted: 28 Jul 2014 (estimated)
Results: Posted 26 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nasopharyngeal and oesophageal temperatures	Experimental	Device: Nasopharyngeal and oesophageal temperature probesAn oesophageal and nasopharyngeal temperature probe will be placed and temperature will be measured at these site

Who may qualify

Ages: 8 months to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nasopharyngeal and oesophageal temperature probesAlso: Covidien, Mon-a-therm™ General Purpose Temperature Probe 400TM, 90050	Device	Nasopharyngeal and oesophageal temperatures

Primary outcome

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

1 secondary outcome

Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%)
Time frame: 6 months

Results and safety

Results posted to the registry on 26 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cuff Inflation and Cuff Deflation Groups	50	50

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

Time frame: 6 months. Mean (95% Confidence Interval). Unit: temperature difference degrees celsius

Measure	Cuff Inflation and Cuff Deflation Groups n = 50
Value	0.10 (0.04 to 0.16)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cuff Inflation and Cuff Deflation Groups	0 of 59 (0%)	3 of 59 (5.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19137809Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
Background: PubMed 11506130Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.
Background: PubMed 20218415Evans DC, Doraiswamy VA, Prosciak MP, Silviera M, Seamon MJ, Rodriguez Funes V, Cipolla J, Wang CF, Kavuturu S, Torigian DA, Cook CH, Lindsey DE, Steinberg SM, Stawicki SP. Complications associated with pulmonary artery catheters: a comprehensive clinical review. Scand J Surg. 2009;98(4):199-208. doi: 10.1177/145749690909800402.
Background: PubMed 9787697Robinson JL, Seal RF, Spady DW, Joffres MR. Comparison of esophageal, rectal, axillary, bladder, tympanic, and pulmonary artery temperatures in children. J Pediatr. 1998 Oct;133(4):553-6. doi: 10.1016/s0022-3476(98)70067-8.
Background: PubMed 13376459SEVERINGHAUS JW, STUPFEL M. Internal body temperature gradients during anesthesia and hypothermia and effect of vagotomy. J Appl Physiol. 1956 Nov;9(3):380-6. doi: 10.1152/jappl.1956.9.3.380. No abstract available.
Background: PubMed 5710916Whitby JD, Dunkin LJ. Temperature differences in the oesophagus. Preliminary study. Br J Anaesth. 1968 Dec;40(12):991-5. doi: 10.1093/bja/40.12.991. No abstract available.
Background: PubMed 5488350Whitby JD, Dunkin LJ. Oesophageal temperature differences in children. Br J Anaesth. 1970 Nov;42(11):1013-5. doi: 10.1093/bja/42.11.1013. No abstract available.
Background: PubMed 15302054Kaukuntla H, Harrington D, Bilkoo I, Clutton-Brock T, Jones T, Bonser RS. Temperature monitoring during cardiopulmonary bypass--do we undercool or overheat the brain? Eur J Cardiothorac Surg. 2004 Sep;26(3):580-5. doi: 10.1016/j.ejcts.2004.05.004.
Background: PubMed 8452743Holtzclaw BJ. Monitoring body temperature. AACN Clin Issues Crit Care Nurs. 1993 Feb;4(1):44-55.
Background: PubMed 7856892Stone JG, Young WL, Smith CR, Solomon RA, Wald A, Ostapkovich N, Shrebnick DB. Do standard monitoring sites reflect true brain temperature when profound hypothermia is rapidly induced and reversed? Anesthesiology. 1995 Feb;82(2):344-51. doi: 10.1097/00000542-199502000-00004.
Background: PubMed 14706007Maxton FJ, Justin L, Gillies D. Estimating core temperature in infants and children after cardiac surgery: a comparison of six methods. J Adv Nurs. 2004 Jan;45(2):214-22. doi: 10.1046/j.1365-2648.2003.02883.x.
Background: PubMed 5564234Whitby JD, Dunkin LJ. Cerebral, oesophageal and nasopharyngeal temperatures. Br J Anaesth. 1971 Jul;43(7):673-6. doi: 10.1093/bja/43.7.673. No abstract available.
National Institute for Health and Clinical Excellence. The management of inadvertent perioperative hypothermia in adults: full guidelineLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aarjan P Snoek, MBChB, FRCA principal investigator

Great Ormond Street Hospital for Children NHS Foundation Trust

Helen V Hume-Smith, MBBS, FRCA principal investigator

Great Ormond Street Hospital for Children NHS Foundation Trust

Emily Haberman, MBBS, FRCA principal investigator

Great Ormond Street Hospital for Children NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nasopharyngeal and oesophageal temperature probes in people with Child, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02201628, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.