Patient Characteristics and Tracheobronchial Anatomy (Scan-Bronchi)
11. juli 2017 opdateret af: Hopital Foch
Influence of Patient Characteristics on the Tracheobronchial Anatomy Evaluated by a CT Examination
The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge of the tracheobronchial anatomy in order to establish the best choice for the patient. The literature is limited regarding major bronchi dimensions. In addition, the measurement method is not always adequate or properly described and some publications have evaluated only the left bronchial diameter. Computed tomography with 3D reconstruction, technical reference, has been little used.
The project is to conduct a prospective study to compare patient characteristics (age, height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if available), and dimensions of the trachea and of the main bronchi from CT scans with 3D reconstruction.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
240
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Suresnes, Frankrig, 92150
- Hôpital Foch
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patients aged at least 18 years
- undergoing a CT scan
Exclusion Criteria:
- hospitalized patients,
- people benefiting from a legal protection.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Studied population
Patients will be questioned about their main characteristics (age, gender, height, weight, smoking), they will also perform a simplified a pulmonary function test (if possible).
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Questionnaire on their main characteristics : age, gender, height, weight, smoking
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Relationship between patients' age and the minimum diameter of the left main bronchus
Tidsramme: 1 year
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Age (years) and diameter (mm)
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1 year
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Relationship between patients' gender and the minimum diameter of the left main bronchus
Tidsramme: 1 year
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Gender (male/female) and diameter (mm)
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1 year
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Relationship between patients' height and the minimum diameter of the left main bronchus
Tidsramme: 1 year
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Height (cm) and diameter (mm)
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1 year
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Relationship between patients' weight and the minimum diameter of the left main bronchus
Tidsramme: 1 year
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Weight (kg) and diameter (mm)
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1 year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Relationship between patients functional test and the minimum diameter of the left main bronchus
Tidsramme: 1 year
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Forced expiratory volume (% of reference value) and diameter (mm)
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1 year
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Relationship between patient characteristics and the measurement of lengths, diameters and cross-sectional areas of the trachea and of right main bronchus
Tidsramme: 1 year
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1 year
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Validation of automatic measurement of tracheal and bronchial diameters
Tidsramme: 1 year
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Comparison between manual and automatic measurement using the software "Thoracic VCAR" of General Electric
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1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Virginie Dumans-Nizard, MD, Hôpital Foch
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
- Breatnach E, Abbott GC, Fraser RG. Dimensions of the normal human trachea. AJR Am J Roentgenol. 1984 May;142(5):903-6. doi: 10.2214/ajr.142.5.903.
- Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.
- Jit H, Jit I. Dimensions & shape of the trachea in the neonates, children & adults in northwest India. Indian J Med Res. 2000 Jul;112:27-33.
- Chunder R, Nandi S, Guha R, Satyanarayana N. A morphometric study of human trachea and principal bronchi in different age groups in both sexes and its clinical implications. Nepal Med Coll J. 2010 Dec;12(4):207-14.
- Zahedi-Nejad N, Bakhshayesh-Karam M, Kahkoei S, Abbasi-Dezfoully A, Masjedi MR. Normal dimensions of trachea and two main bronchi in the Iranian population. Pol J Radiol. 2011 Oct;76(4):28-31.
- Robinson CL, Muller NL, Essery C. Clinical significance and measurement of the length of the right main bronchus. Can J Surg. 1989 Jan;32(1):27-8.
- Eberle B, Weiler N, Vogel N, Kauczor HU, Heinrichs W. Computed tomography-based tracheobronchial image reconstruction allows selection of the individually appropriate double-lumen tube size. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):532-7. doi: 10.1016/s1053-0770(99)90003-4.
- Olivier P, Hayon-Sonsino D, Convard JP, Laloe PA, Fischler M. Measurement of left mainstem bronchus using multiplane CT reconstructions and relationship between patient characteristics or tracheal diameters and left bronchial diameters. Chest. 2006 Jul;130(1):101-7. doi: 10.1378/chest.130.1.101.
- Kamel KS, Lau G, Stringer MD. In vivo and in vitro morphometry of the human trachea. Clin Anat. 2009 Jul;22(5):571-9. doi: 10.1002/ca.20815.
- Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
- Mrudula C, Krishnaiah M. The study of bronchial tree. International Journal of Pharma and Bio Sciences 2011;2:B166-B172
- Otoch JP, Minamoto H, Perini M, Carneiro FO, de Almeida Artifon EL. Is there a correlation between right bronchus length and diameter with age? J Thorac Dis. 2013 Jun;5(3):306-9. doi: 10.3978/j.issn.2072-1439.2013.03.12.
- Kim JH, Park SH, Han SH, Nahm FS, Jung CK, Kim KM. The distance between the carina and the distal margin of the right upper lobe orifice measured by computerised tomography as a guide to right-sided double-lumen endobronchial tube use. Anaesthesia. 2013 Jul;68(7):700-5. doi: 10.1111/anae.12208. Epub 2013 May 8.
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
1. juni 2015
Primær færdiggørelse (Faktiske)
21. november 2016
Studieafslutning (Faktiske)
21. november 2016
Datoer for studieregistrering
Først indsendt
26. maj 2016
Først indsendt, der opfyldte QC-kriterier
2. juni 2016
Først opslået (Skøn)
8. juni 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2014/25
- 2014-A00826-41 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .