NCT03088761

Brief Summary

The changes in the cuff pressure in the absence of nitrous oxide are less clear.In the current study, we aim to determine the changes in cuff pressure over time in infants undergoing myelomeningocele repair in prone position under general anesthesia in the absence of N2O.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

March 18, 2017

Last Update Submit

April 12, 2017

Conditions

MyelomeningoceleProne Position

Keywords

tracheal tubecuff pressure

Outcome Measures

Primary Outcomes (1)

  • the change in cuff pressure

    the change in cuff pressure will be recorded during prone position

    four months

Study Arms (1)

cuffed tube pressure group

The pressures of cuffed tracheal tubes will be monitored simultaneously with a cuff manometer and pressure transducer. The measurements will be observed continuously. When the cuff pressure is noted to exceed 15 cmH2O, the cuff will be deflated immediately to less than 15 cmH2O. The time when the correction occurred, the time interval between corrections and the number of corrections during surgery will be recorded. The baseline cuff pressure will be assessed in the supine position after which time a second measurement will be made in the prone position. A blind investigator will check and record the findings of cuffed tracheal tube.

Device: cuffed tracheal tube

Interventions

cuffed tracheal tubeDEVICE

the changes in cuff pressure will be determined using a cuff manometer

cuffed tube pressure group

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

1-30 days old infants undergoing meningomyelocele repair

You may qualify if:

  • male and female infants undergoing meningomyelocele repair

You may not qualify if:

  • tracheal intubation with uncuffed tube, the use of N2O during anesthesia, accompanying disease like hydrocephalus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Motoyama A, Asai S, Konami H, Matsumoto Y, Misumi T, Imanaka H, Nishimura M. Changes in endotracheal tube cuff pressure in mechanically ventilated adult patients. J Intensive Care. 2014 Jan 31;2(1):7. doi: 10.1186/2052-0492-2-7. eCollection 2014.

    PMID: 25520824RESULT

  • Kako H, Alkhatib O, Krishna SG, Khan S, Naguib A, Tobias JD. Changes in intracuff pressure of a cuffed endotracheal tube during surgery for congenital heart disease using cardiopulmonary bypass. Paediatr Anaesth. 2015 Jul;25(7):705-10. doi: 10.1111/pan.12631. Epub 2015 Mar 4.

    PMID: 25735902RESULT

  • Lizy C, Swinnen W, Labeau S, Poelaert J, Vogelaers D, Vandewoude K, Dulhunty J, Blot S. Cuff pressure of endotracheal tubes after changes in body position in critically ill patients treated with mechanical ventilation. Am J Crit Care. 2014 Jan;23(1):e1-8. doi: 10.4037/ajcc2014489.

    PMID: 24382623RESULT

  • Nseir S, Brisson H, Marquette CH, Chaud P, Di Pompeo C, Diarra M, Durocher A. Variations in endotracheal cuff pressure in intubated critically ill patients: prevalence and risk factors. Eur J Anaesthesiol. 2009 Mar;26(3):229-34. doi: 10.1097/eja.0b013e3283222b6e.

    PMID: 19244697RESULT

  • Orsborn J, Graham J, Moss M, Melguizo M, Nick T, Stroud M. Pediatric Endotracheal Tube Cuff Pressures During Aeromedical Transport. Pediatr Emerg Care. 2016 Jan;32(1):20-2. doi: 10.1097/PEC.0000000000000365.

    PMID: 25834962RESULT

  • Beydon L, Gourgues M, Talec P. [Endotracheal tube cuff and nitrous oxide: bench evaluation and assessment of clinical practice]. Ann Fr Anesth Reanim. 2011 Sep;30(9):679-84. doi: 10.1016/j.annfar.2011.03.017. Epub 2011 Jun 25. French.

    PMID: 21705180RESULT

  • 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: 10389801RESULT

  • Plotnikow GA, Roux N, Feld V, Gogniat E, Villalba D, Ribero NV, Sartore M, Bosso M, Quiroga C, Leiva V, Scrigna M, Puchulu F, Distefano E, Scapellato JL, Intile D, Planells F, Noval D, Bunirigo P, Jofre R, Nielsen ED. Evaluation of tracheal cuff pressure variation in spontaneously breathing patients. Int J Crit Illn Inj Sci. 2013 Oct;3(4):262-8. doi: 10.4103/2229-5151.124148.

    PMID: 24459624RESULT

  • Godoy AC, Vieira RJ, Capitani EM. Endotracheal tube cuff pressure alteration after changes in position in patients under mechanical ventilation. J Bras Pneumol. 2008 May;34(5):294-7. doi: 10.1590/s1806-37132008000500008. English, Portuguese.

    PMID: 18545825RESULT

  • Tan PH, Lin VC, Chen HS, Hung KC. The effect of transoesophageal echocardiography probe insertion on tracheal cuff pressure. Anaesthesia. 2011 Sep;66(9):791-5. doi: 10.1111/j.1365-2044.2011.06789.x. Epub 2011 Jun 24.

    PMID: 21707563RESULT

  • Tobias JD. Applications of nitrous oxide for procedural sedation in the pediatric population. Pediatr Emerg Care. 2013 Feb;29(2):245-65. doi: 10.1097/PEC.0b013e318280d824.

    PMID: 23546436RESULT

  • Maino P, Dullenkopf A, Bernet V, Weiss M. Nitrous oxide diffusion into the cuffs of disposable laryngeal mask airways. Anaesthesia. 2005 Mar;60(3):278-82. doi: 10.1111/j.1365-2044.2004.04072.x.

    PMID: 15710013RESULT

  • Kako H, Krishna SG, Ramesh AS, Merz MN, Elmaraghy C, Grischkan J, Jatana KR, Ruda J, Tobias JD. The relationship between head and neck position and endotracheal tube intracuff pressure in the pediatric population. Paediatr Anaesth. 2014 Mar;24(3):316-21. doi: 10.1111/pan.12308. Epub 2013 Nov 18.

    PMID: 24238105RESULT

  • Grant T. Do current methods for endotracheal tube cuff inflation create pressures above the recommended range? A review of the evidence. J Perioper Pract. 2013 Dec;23(12):292-5. doi: 10.1177/175045891302301205.

    PMID: 24404708RESULT

  • Krishna SG, Ramesh AS, Jatana KR, Elmaraghy C, Merz M, Ruda J, Tobias JD. A technique to measure the intracuff pressure continuously: an in vivo demonstration of its accuracy. Paediatr Anaesth. 2014 Sep;24(9):999-1004. doi: 10.1111/pan.12437. Epub 2014 May 24.

    PMID: 24860935RESULT

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kemal T Saracoglu

    Istanbul Science University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kemal T Saracoglu, MD

CONTACT

+905385478620saracoglukt@gmail.com

Aten Saracoglu, MD

CONTACT

+905377810144anesthesiayten@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor MD

Study Record Dates

First Submitted

March 18, 2017

First Posted

March 23, 2017

Study Start

May 1, 2017

Primary Completion

September 30, 2017

Study Completion

October 1, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04