Comparison Between Two Endotracheal Tube Cuff Inflation Methods

Endotracheal Cuff Pressure Clinical Trial

Official title:

Comparison Between Two Endotracheal Tube Cuff Inflation Methods; Flow Volume Loop Guided vs. Just Seal by Stethoscope Guided in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902756
• Other study ID #: 04-61-24?
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: March 2020
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective randomized controlled trial, the primary aim of this study to compare the intracuff pressure which is performed by 2 inflation methods. ( study in pediatric patients 4-12 year old) Group1 : Flow -Volume Loop-guided cuff inflation Group2 : Stethoscope-guided cuff inflation Our hypothesis is Flow-Volume Loop-guided cuff pressure will be lower than Stethoscope-guided cuff pressure.

This study also collect the incidence of common post-extubation respiratory adverse events coughing, hoarseness, stridor, croup as an secondary outcomes.

Description:

Historically, pediatric anesthesiologists abstained from using cuff-endotracheal tubes in children younger than 8 year of age because of the anatomical particularises of their airway and thus the increased risk of postintubation tracheal damage especially when Nitrous oxide is used for long procedures. In addition the tube size shoud be half size reduced when cuffed endotracheal tube is used, leading to higher airway resistance and increased risk of tube obstruction.

Recently, the use of Cuffed endotracheal tube has been increasing in children younger than 8 year of age who undergoing general anesthesia. Due to several reasons as follows 1) an increasingly sophisticated understanding of developing laryngeal anatomy 2) vastly improved materials in the manufacture of endotracheal tubes 3) cuffed endotracheal tubes serve several advantages over uncuffed endotracheal tubes including fewer laryngoscopies to replace ill-fitting tubes, less contamination of operating room with anesthetic gases, reliable capnography monitoring, better protection against aspiration, adequate ventilation with a low fresh gas flow which allow using low flow anesthsia, and also they are advantageous for certain operations such as laparoscopic/ airway procedures. 4) data are plentiful supporting the equal safety of using cuffed endotracheal tubes compared with uncuffed tubes in children However, using cuffed endotracheal tubes without being careful of cuff pressure may result in damage to tracheal mucosal wall especially in pediatric patients. The intra-cuff pressure should be monitored and maintained at the level below 25 cm H2O. The intra-cuff pressure more than 30 cmH2O causes obstruction to mucosal blood flow and increasing the risk of airway mucosal injury. Cuff pressure measurement by manometer is a gold standard, nevertheless manometer is not available in every operating room. Almost of anesthetists often use either manual palpation of pilot balloon or stethoscope-guided to inflate endotracheal tube cuff.

In adult studies, they found that endotracheal tube cuff pressure estimated by palpation even with experience personals is often much higher than 25-30 cmH2O. Therefore this inflation technique should be avoided in pediatric patients.

As for, stethoscope-guided endotracheal cuff inflation which pediatric anesthesiologists usually use for children. There were several studies in adult patients, they found the median cuff pressure from this inflation technique was 20 (16-28) cmH2O which is in acceptable tracheal cuff pressure.

In routine practice of general anesthesia rarely have continuous cuff pressure monitoring. When Nitrous Oxide is used for general anesthesia, the intra-cuff pressure can increase with time. Accordingly, it will be better to keep intra-cuff pressure as low as having proper sealing.

A couple studies from adult, compared endotracheal tube cuff inflation techniques between Pressure-Volume(PV) loop guided and stethoscope-guided and the results were intra-cuff pressure from PV loop guided was less than stethoscope guided. Moreover cuff-related complications ( coughing, sorethroat) were less in PV loop group also. It seems PV loop guided can provide least cuff pressure with efficient sealing.

This study would like to compare endotracheal cuff pressure that are performed by 2 techniques between Flow-Volume(FV) loop guided and stethoscope-guided in pediatric patients Intra-cuff pressure will be the primary outcome and we will also collect postoperative respiratory complications such as coughing, stridor, hoarseness as secondary outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients are undergoing an operations in Ramathibodi hospital.

• American Society of Anesthesiologists physical status class 1-2

• Endotracheal tube intubation is needed for an operation

• Consent to participate in research project.

Exclusion Criteria:

• Patient who is a predicted difficult intubation

• Patient who has lung disease, airwar abnormalities

• Patient who has pulmonary aspiration risk

• Patient who has a previous sorethroat, hoarseness, respiratory tract infection in last 2 weeks

• Refused to participate in research project

Related Conditions & MeSH terms

• Endotracheal Cuff Pressure
• Flow-Volume Loop Guided
• Stethoscope-guided

Intervention

Other:
• Endotracheal cuff inflation
Endotracheal cuff inflation is putting the air in to the endotracheal tube cuff to make the proper sealing.

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Bangkok	Ratchathewi

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (22)

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Borhazowal R, Harde M, Bhadade R, Dave S, Aswar SG. Comparison between Two Endotracheal Tube Cuff Inflation Methods; Just-Seal Vs. Stethoscope-Guided. J Clin Diagn Res. 2017 Jun;11(6):UC01-UC03. doi: 10.7860/JCDR/2017/26301.10017. Epub 2017 Jun 1. — View Citation

Dalal PG, Murray D, Feng A, Molter D, McAllister J. Upper airway dimensions in children using rigid video-bronchoscopy and a computer software: description of a measurement technique. Paediatr Anaesth. 2008 Jul;18(7):645-53. doi: 10.1111/j.1460-9592.2008.02533.x. Epub 2008 May 8. — View Citation

Dalal PG, Murray D, Messner AH, Feng A, McAllister J, Molter D. Pediatric laryngeal dimensions: an age-based analysis. Anesth Analg. 2009 May;108(5):1475-9. doi: 10.1213/ane.0b013e31819d1d99. — View Citation

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Dullenkopf A, Schmitz A, Gerber AC, Weiss M. Tracheal sealing characteristics of pediatric cuffed tracheal tubes. Paediatr Anaesth. 2004 Oct;14(10):825-30. — View Citation

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Hoffman RJ, Parwani V, Hahn IH. Experienced emergency medicine physicians cannot safely inflate or estimate endotracheal tube cuff pressure using standard techniques. Am J Emerg Med. 2006 Mar;24(2):139-43. — View Citation

Holzki J, Brown KA, Carroll RG, Coté CJ. The anatomy of the pediatric airway: Has our knowledge changed in 120 years? A review of historic and recent investigations of the anatomy of the pediatric larynx. Paediatr Anaesth. 2018 Jan;28(1):13-22. doi: 10.1111/pan.13281. Epub 2017 Nov 17. Review. — View Citation

Khine HH, Corddry DH, Kettrick RG, Martin TM, McCloskey JJ, Rose JB, Theroux MC, Zagnoev M. Comparison of cuffed and uncuffed endotracheal tubes in young children during general anesthesia. Anesthesiology. 1997 Mar;86(3):627-31; discussion 27A. — View Citation

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Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24. — View Citation

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. — View Citation

Shi F, Xiao Y, Xiong W, Zhou Q, Huang X. Cuffed versus uncuffed endotracheal tubes in children: a meta-analysis. J Anesth. 2016 Feb;30(1):3-11. doi: 10.1007/s00540-015-2062-4. Epub 2015 Aug 22. Review. — View Citation

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. Review. — 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):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-cuff pressure	measuring intra-cuff pressure of endotracheal tube by manometer (cm H2O)	Immediately after cuff inflation
Secondary	Coughing	incidence of coughing	24 hours after extubation
Secondary	Hoarseness	incidence of hoarseness	24 hours after extubation
Secondary	Stridor	incidence of stridor	24 hours after extubation