Paediatric Microcuff Pressure Study

NCT03240354 | Completed

• 1 other identifier: 17AN003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

In paediatric anaesthesia, use of cuffed endotracheal (ET) tubes is subject to much debate. The concern is the possibility of damage to tracheal mucosa by excessive pressure from the cuff. The cuff pressure can increase during anaesthesia, especially if nitrous oxide is used. Using saline to inflate the cuff has been shown to reduce intra-operative cuff pressure variation in adult studies, although it is not standard practice. Although the literature contains reports of cuff pressure increases during paediatric anaesthesia, there are no reports of attempts to address this. Use of pressure monitoring is recommended by AAGBI, but may not be consistently done. A safe method of limiting pressure, that is effective, imposes minimal extra workload and has minimal cost, would reduce risk to patients. This study aims to investigate the effect on intra-operative cuff pressure of using saline to inflate the ET tube cuff, compared to standard practice of air inflation. Continuous pressure monitoring will be used to determine the proportion of cases where interventions are required to keep the pressure below a safe maximum level.

Conditions

Anesthesia; Pediatric; Intubation Complication

Outcome Measures

Primary Outcomes (1)

• The number of cases where an intervention was required to maintain cuff pressure below 25cm H2O

  * During anaesthesia, the pressure in the ET tube cuff will be measured continuously by an investigator, separate from the team providing the anaesthesia, using an arterial line pressure transducer set attached to the pilot balloon through a 3-way tap. The initial cuff pressure will be recorded ('Pressure 0') * The cuff pressure will be documented every 5 minutes. * If the cuff pressure exceeds 25 cm H2O for more than 30 seconds (to exclude artefactual changes), the volume of fluid in the cuff will be reduced until the pressure is returned to the initial level ('Pressure 0'). * This constitutes an 'Intervention'

  Intra-operative, 45min - 6 hours

Secondary Outcomes (3)

• Cuff pressure in each group

  Intra-operative, 45min - 6 hours

• Post extubation adverse events

  up to 20min Post extubation

• Post-operative airway complications

  up to 24 hours post-op

Study Arms (2)

Saline

EXPERIMENTAL

Use of saline to inflate cuff of endotracheal tube

Device: Saline cuff

Control

ACTIVE COMPARATOR

Use of air to inflate cuff of endotracheal tube

Device: Control

Interventions

Saline cuff DEVICE

Cuff of endotracheal tube inflated with saline rather than air (control)

Saline

Control DEVICE

Cuff of endotracheal tube inflated with air

Control

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/guardian's written informed consent / age-appropriate participant assent
• Age: Birth to 16 years
• Elective surgery
• Endotracheal intubation with a cuffed tube required as part of general anaesthesia lasting longer than 45 minutes
• Planned use of N2O as part of balanced anaesthesia
• For questionnaire follow up; aged over 8 years without significant neurological impairment

You may not qualify if:

• Weight less than 3kg
• Laryngeal or tracheal pathology, including respiratory tract infections
• Difficulty in intubation (\>2 attempts)
• NG tube placement during anaesthesia
• Nose, throat or airway surgery

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospital

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (17)

• Lonnqvist PA. Cuffed or uncuffed tracheal tubes during anaesthesia in infants and small children: time to put the eternal discussion to rest? Br J Anaesth. 2009 Dec;103(6):783-5. doi: 10.1093/bja/aep330. No abstract available.

  PMID: 19918019 BACKGROUND

• Tobias JD. Pediatric airway anatomy may not be what we thought: implications for clinical practice and the use of cuffed endotracheal tubes. Paediatr Anaesth. 2015 Jan;25(1):9-19. doi: 10.1111/pan.12528. Epub 2014 Sep 20.

  PMID: 25243638 BACKGROUND

• 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):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.

  PMID: 19887533 BACKGROUND

• Suominen P, Taivainen T, Tuominen N, Voipio V, Wirtavuori K, Hiller A, Korpela R, Karjalainen T, Meretoja O. Optimally fitted tracheal tubes decrease the probability of postextubation adverse events in children undergoing general anesthesia. Paediatr Anaesth. 2006 Jun;16(6):641-7. doi: 10.1111/j.1460-9592.2005.01832.x.

  PMID: 16719880 BACKGROUND

• Checketts MR, Jenkins B, Pandit JJ. Implications of the 2015 AAGBI recommendations for standards of monitoring during anaesthesia and recovery. Anaesthesia. 2017 Jan;72 Suppl 1:3-6. doi: 10.1111/anae.13736. No abstract available.

  PMID: 28044335 BACKGROUND

• Dullenkopf A, Gerber AC, Weiss M. Nitrous oxide diffusion into tracheal tube cuffs: comparison of five different tracheal tube cuffs. Acta Anaesthesiol Scand. 2004 Oct;48(9):1180-4. doi: 10.1111/j.1399-6576.2004.00483.x.

  PMID: 15352966 BACKGROUND

• Felten ML, Schmautz E, Delaporte-Cerceau S, Orliaguet GA, Carli PA. Endotracheal tube cuff pressure is unpredictable in children. Anesth Analg. 2003 Dec;97(6):1612-1616. doi: 10.1213/01.ANE.0000087882.04234.11.

  PMID: 14633529 BACKGROUND

• Tu HN, Saidi N, Leiutaud T, Bensaid S, Menival V, Duvaldestin P. Nitrous oxide increases endotracheal cuff pressure and the incidence of tracheal lesions in anesthetized patients. Anesth Analg. 1999 Jul;89(1):187-90. doi: 10.1097/00000539-199907000-00033.

  PMID: 10389801 BACKGROUND

• Karasawa F, Ohshima T, Takamatsu I, Ehata T, Fukuda I, Uchihashi Y, Satoh T. The effect on intracuff pressure of various nitrous oxide concentrations used for inflating an endotracheal tube cuff. Anesth Analg. 2000 Sep;91(3):708-13. doi: 10.1097/00000539-200009000-00040.

  PMID: 10960405 BACKGROUND

• Combes X, Schauvliege F, Peyrouset O, Motamed C, Kirov K, Dhonneur G, Duvaldestin P. Intracuff pressure and tracheal morbidity: influence of filling with saline during nitrous oxide anesthesia. Anesthesiology. 2001 Nov;95(5):1120-4. doi: 10.1097/00000542-200111000-00015.

  PMID: 11684980 BACKGROUND

• Bennett MH, Isert PR, Cumming RG. Postoperative sore throat and hoarseness following tracheal intubation using air or saline to inflate the cuff--a randomized controlled trial. Anaesth Intensive Care. 2000 Aug;28(4):408-13. doi: 10.1177/0310057X0002800409.

  PMID: 10969368 BACKGROUND

• Tobias JD, Schwartz L, Rice J, Jatana K, Kang DR. Cuffed endotracheal tubes in infants and children: should we routinely measure the cuff pressure? Int J Pediatr Otorhinolaryngol. 2012 Jan;76(1):61-3. doi: 10.1016/j.ijporl.2011.09.033. Epub 2011 Oct 22.

  PMID: 22024576 BACKGROUND

• Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8. doi: 10.1136/bmj.288.6422.965.

  PMID: 6423162 BACKGROUND

• Sheraton TE, Gildersleve CD, Hall JE. The use of nitrous oxide in paediatric anaesthetic practice in the United Kingdom: a questionnaire survey. Anaesthesia. 2007 Jan;62(1):62-6. doi: 10.1111/j.1365-2044.2006.04857.x.

  PMID: 17156228 BACKGROUND

• Constant I, Louvet N, Guye ML, Sabourdin N. [General anaesthesia in children: a French survey of practices]. Ann Fr Anesth Reanim. 2012 Sep;31(9):709-23. doi: 10.1016/j.annfar.2012.06.004. Epub 2012 Jul 7. French.

  PMID: 22776772 BACKGROUND

• Calder A, Hegarty M, Erb TO, von Ungern-Sternberg BS. Predictors of postoperative sore throat in intubated children. Paediatr Anaesth. 2012 Mar;22(3):239-43. doi: 10.1111/j.1460-9592.2011.03727.x. Epub 2011 Nov 8.

  PMID: 22066487 BACKGROUND

• Armstrong J, Jenner P, Poulose S, Moppett IK. The effect of saline versus air for cuff inflation on the incidence of high intra-cuff pressure in paediatric MicroCuff(R) tracheal tubes: a randomised controlled trial. Anaesthesia. 2021 Nov;76(11):1504-1510. doi: 10.1111/anae.15493. Epub 2021 Apr 23.

  PMID: 33891328 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * Participants will be split into two age groups, 'under 8 years' and '8 years and over', and a stratified randomisation method will be used to randomise each group, using a previously verified, sealed envelope, method and using blocks of unequal size. * Envelopes will be prepared using a random number table by an individual with no further role in the study * Each participant will be given a unique randomisation code matching the randomisation list * A record of each randomisation will be recorded on the Enrolment Log (TAFR01502)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, blinded, randomised, parallel group control trial

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: August 7, 2017
• Study Start: August 6, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: February 20, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)