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)

Bloch EC, Ginsberg B, Binner RA Jr. The esophageal temperature gradient in anesthetized children. J Clin Monit. 1993 Apr;9(2):73-7. doi: 10.1007/BF01616917. — View Citation

Cronin K, Wallis M. Temperature taking in the ICU: which route is best? Aust Crit Care. 2000 May;13(2):59-64. doi: 10.1016/s1036-7314(00)70623-0. — View Citation

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. — View Citation

Holtzclaw BJ. Monitoring body temperature. AACN Clin Issues Crit Care Nurs. 1993 Feb;4(1):44-55. — View Citation

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. — View Citation

Ko HK, Flemmer A, Haberl C, Simbruner G. Methodological investigation of measuring nasopharyngeal temperature as noninvasive brain temperature analogue in the neonate. Intensive Care Med. 2001 Apr;27(4):736-42. doi: 10.1007/s001340000829. — View Citation

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. — View Citation

Matsukawa T, Ozaki M, Sessler DI, Nishiyama T, Imamura M, Kumazawa T. Accuracy and precision of "deep sternal" and tracheal temperatures at high- and low-fresh-gas flows. Br J Anaesth. 1998 Aug;81(2):171-5. doi: 10.1093/bja/81.2.171. — View Citation

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. — View Citation

Mekjavic IB, Rempel ME. Determination of esophageal probe insertion length based on standing and sitting height. J Appl Physiol (1985). 1990 Jul;69(1):376-9. doi: 10.1152/jappl.1990.69.1.376. — View Citation

Muravchick S. Deep body thermometry during general anesthesia. Anesthesiology. 1983 Mar;58(3):271-5. doi: 10.1097/00000542-198303000-00014. No abstract available. — View Citation

Paik UH, Lee TR, Kang MJ, Shin TG, Sim MS, Jo IJ, Song KJ, Jeong YK. Success rates and procedure times of oesophageal temperature probe insertion for therapeutic hypothermia treatment of cardiac arrest according to insertion methods in the emergency department. Emerg Med J. 2013 Nov;30(11):896-900. doi: 10.1136/emermed-2012-201579. Epub 2012 Nov 17. — View Citation

Ramsay JG, Ralley FE, Whalley DG, DelliColli P, Wynands JE. Site of temperature monitoring and prediction of afterdrop after open heart surgery. Can Anaesth Soc J. 1985 Nov;32(6):607-12. doi: 10.1007/BF03011406. — View Citation

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. — View Citation

Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available. — View Citation

Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76. — View Citation

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. — View Citation

Smith JH, Keltie K, Murphy T, Raj N, Lane M, Ranger M, Sims AJ. A comparison of three methods that assess tracheal tube leakage: leak conductance, fractional volume loss, and audible assessment. Paediatr Anaesth. 2013 Feb;23(2):111-6. doi: 10.1111/pan.12043. Epub 2012 Oct 13. — View Citation

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. — View Citation

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. — View Citation

Taylor C, Subaiya L, Corsino D. Pediatric cuffed endotracheal tubes: an evolution of care. Ochsner J. 2011 Spring;11(1):52-6. — View Citation

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. — View Citation

Wass CT, Long TR, Deschamps C. Entrapment of a nasopharyngeal temperature probe: an unusual complication during an apparently uneventful elective revision laparoscopic Nissen fundoplication. Dis Esophagus. 2010 Jan;23(1):33-5. doi: 10.1111/j.1442-2050.2009.00968.x. Epub 2009 Apr 15. — View Citation

Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6) — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Williams DJ, Kelleher AA. Defective nasopharyngeal temperature probes. Anaesthesia. 2002 Dec;57(12):1223; author reply 1223-4. doi: 10.1046/j.1365-2044.2002.02913_18.x. No abstract available. — View Citation

* 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