Neck Movement Implicate the Tracheal Tube-tip Displacement in Pediatric Surgery
8. juli 2020 opdateret af: Yan Siyi, Beijing Tsinghua Chang Gung Hospital
Neck Flexion and Extension Implicate the Tracheal Tube-tip Displacement in Children Undergoing Head and Neck Surgeries
This study evaluates the effect of head and neck movement in children on endotracheal tube (ETT) tip displacement undergoing head-and-neck surgeries.
The tube-tip displacement will be measured using flexible fiberoptic bronchoscope.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
In clinical application, especially in head-and-neck surgeries, the operators often change the position of children's head-neck for easy operating. Flexing the head resulted in the ETT moving towards the carina, and extension resulted in the tube being displaced in the opposite direction. Head and neck movement change the length of trachea as well: extending the head resulted in the extension of trachea, while flexing resulted in the opposite. Serious complications following from head and neck movement, such as accidental extubation and endobronchial intubation, threat children's life.
In pediatric anesthesia, insertion depth (cm) of orotracheal intubation equals to age/2+12, according to classic intubation formulae. The ETT will be put in the depth calculated by the classic formulae under general anesthesia. The distance of ETT-tip displacement and the length change of trachea will be measured as the head and neck placed as follows: fully extended, neutral position, or fully flexed. These three head and neck positions imitate the head-neck movement during those head-and-neck surgeries.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
172
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 102218
- Department of Anesthesia, Beijing Tsinghua Chang Gung Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 14 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Children who schedul to undergo elective head-and-neck surgeries under general anesthesia with orotracheal intubation will be enrolled.
Beskrivelse
Inclusion Criteria:
- subject has elective head-and-neck surgery schedule
- subject will have orotracheal intubation under general anesthesia
Exclusion Criteria:
- subject has malformations of the trachea or bronchus on chest X-ray
- subject has spinal deformity
- subject has difficulties in neck flexion or extension
- subject has neck pain
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Distance of trachea carina (TC) to endotracheal tube (ETT) tip
Tidsramme: 10min (time that the measurement need)
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Measure the distance between trachea carina to the tip of ETT in three different neck-head positions: fully flexion, neutral positon and fully extension.
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10min (time that the measurement need)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Distance of tracheal length
Tidsramme: 10min (time that the measurement need)
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Tracheal length equals the distance between trachea carina (TC) to posterior vocal commissure.
Measure Tracheal length in three different neck-head positions: fully flexion, neutral positon and fully extension.
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10min (time that the measurement need)
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Serious complication of unexpected displacement of the endotracheal tube: accidental extubation
Tidsramme: intraoperative
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When the operator put the child's neck into extension position, accidental extubation may occur, which can lead to hypoxia and asphyxia.
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intraoperative
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Serious complication of unexpected displacement of the endotracheal tube: endobronchial intubation.
Tidsramme: intraoperative
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When the operator put the child's neck into flexion position, accidental endobronchial intubation may occur, which can lead to one-lung ventilation and pulmonary edema.
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intraoperative
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: SIYI YAN, MD, Beijing Tsinghua Chang Gung Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Dronen S, Chadwick O, Nowak R. Endotracheal tip position in the arrested patient. Ann Emerg Med. 1982 Feb;11(2):116-7. doi: 10.1016/s0196-0644(82)80328-4. No abstract available.
- McCoy EP, Russell WJ, Webb RK. Accidental bronchial intubation. An analysis of AIMS incident reports from 1988 to 1994 inclusive. Anaesthesia. 1997 Jan;52(1):24-31. doi: 10.1111/j.1365-2044.1997.007-az007.x.
- Mariano ER, Ramamoorthy C, Chu LF, Chen M, Hammer GB. A comparison of three methods for estimating appropriate tracheal tube depth in children. Paediatr Anaesth. 2005 Oct;15(10):846-51. doi: 10.1111/j.1460-9592.2005.01577.x.
- Lau N, Playfor SD, Rashid A, Dhanarass M. New formulae for predicting tracheal tube length. Paediatr Anaesth. 2006 Dec;16(12):1238-43. doi: 10.1111/j.1460-9592.2006.01982.x.
- Gamble JJ, McKay WP, Wang AF, Yip KA, O'Brien JM, Plewes CE. Three-finger tracheal palpation to guide endotracheal tube depth in children. Paediatr Anaesth. 2014 Oct;24(10):1050-5. doi: 10.1111/pan.12452. Epub 2014 Jun 23.
- Bloch EC, Ossey K, Ginsberg B. Tracheal intubation in children: a new method for assuring correct depth of tube placement. Anesth Analg. 1988 Jun;67(6):590-2. No abstract available.
- Weiss M, Knirsch W, Kretschmar O, Dullenkopf A, Tomaske M, Balmer C, Stutz K, Gerber AC, Berger F. Tracheal tube-tip displacement in children during head-neck movement--a radiological assessment. Br J Anaesth. 2006 Apr;96(4):486-91. doi: 10.1093/bja/ael014. Epub 2006 Feb 7.
- Jin-Hee K, Ro YJ, Seong-Won M, Chong-Soo K, Seong-Deok K, Lee JH, Jae-Hyon B. Elongation of the trachea during neck extension in children: implications of the safety of endotracheal tubes. Anesth Analg. 2005 Oct;101(4):974-977. doi: 10.1213/01.ane.0000169330.92707.1e.
- Kim JT, Kim HJ, Ahn W, Kim HS, Bahk JH, Lee SC, Kim CS, Kim SD. Head rotation, flexion, and extension alter endotracheal tube position in adults and children. Can J Anaesth. 2009 Oct;56(10):751-6. doi: 10.1007/s12630-009-9158-y. Epub 2009 Jul 29.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. marts 2017
Primær færdiggørelse (Faktiske)
30. september 2018
Studieafslutning (Faktiske)
31. december 2018
Datoer for studieregistrering
Først indsendt
1. februar 2017
Først indsendt, der opfyldte QC-kriterier
6. februar 2017
Først opslået (Skøn)
7. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juli 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 12015C1043
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
After recruiting, upload the distance of trachea carina(TC) to endotracheal tube (ETT) tip and the distance of tracheal length of each volunteer.
IPD-delingstidsramme
Real time access
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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