- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04101734
TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes
26. april 2020 opdateret af: Piotr Palaczyński, Medical University of Silesia
Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Double Lumen Video Tubes
The purpose of this study is to assess the usefulness of the Thyromental Height Test in prediction of difficult intubation and the utility of double lumen video endotracheal tubes in patients scheduled for elective thoracic procedures.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Most of the thoracic surgery interventions require lung isolation techniques.
Currently the most commonly used lung isolation techniques are double lumen tubes or single lumen tubes with additional use of bronchial blockers.
In both cases fiberoptic bronchoscopy is used for proper placement and maintenance during operation.
Recently double lumen video endotracheal tubes were proposed as a new alternative for lung isolation techniques.
The double lumen video endotracheal tube differs significantly in size and physical characteristics from standard single lumen endotracheal tube and intubation may prove to be challenging even for an experienced practitioner.
Therefore proper prediction of difficult intubation play a crucial role in a clinical setting.
Sensitivity and specificity of existing anthropometric scales and tests used for prediction of difficult intubation seem lacking so new methods such as Thyromental Height Test (TMHT) are being introduced.
It is based on the height between the anterior border of the thyroid cartilage and the anterior border of the mentum, measured while the patient lies in the supine position with closed mouth.
The main objective of the trial is to assess the clinical usefulness of TMHT in prediction of difficult intubation using double lumen video endotracheal tubes in patients scheduled for elective thoracic surgical procedures.
The secondary aim is to evaluate the utility of double lumen video endotracheal tubes as a novel method of lung separation.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
60
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Silesia
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Zabrze, Silesia, Polen, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1
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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
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Consecutive patients undergoing elective thoracic procedures in university hospital, requiring general anaesthesia and intubation with a double lumen endotracheal tubes.
Beskrivelse
Inclusion Criteria:
- patients scheduled for elective thoracic procedures, requiring general anaesthesia and intubation with double lumen endotracheal tubes
- written, informed consent for participation in the trail
- older than 18 years
Exclusion Criteria:
- emergency procedures
- visible anatomic abnormalities
- patients scheduled for awake fibre optic intubation
- lack of consent for participation in the trail
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Double Lumen Endotracheal Tube
Group of patients intubated with Double Lumen Endotracheal Tube.
|
Intubation was performed with Double Lumen Endotracheal Tube.
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Double Lumen Video Endotracheal Tube
Group of patients intubated with Double Lumen Video Endotracheal Tube.
|
Intubation was performed with Double Lumen Video Endotracheal Tube.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Thyromental height
Tidsramme: Preoperative (1 day prior to the operation)
|
The height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible), in supine position with mouth closed, measured with a depth gauge during routine preoperative anaesthetic visit.
|
Preoperative (1 day prior to the operation)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time of Intubation
Tidsramme: Intraoperatively
|
Time of intubation defined as a time from direct laryngoscopy to proper placement of double lumen endotracheal tube measured with a timer during induction of general anesthesia.
|
Intraoperatively
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Airway trauma
Tidsramme: Intraoperative
|
During fiberoptic bronchoscopy after the operation airway trauma on the level of bronchus, tracheal bifurcation, trachea and vocal cords were reported, where 0 was defined as no visible trauma, 1 as a redness, 2 as oedema, 3 as hematoma and 4 as active bleeding.
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Intraoperative
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Usage of fiberoptic bronchoscopy
Tidsramme: Intraoperatively
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Usage of fiberoptic bronchoscopy for proper placement of double lumen tube was noted.
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Intraoperatively
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score in Cormack-Lehane scale
Tidsramme: Preoperative (1 day prior to the operation)
|
During direct laryngoscopy the laryngeal view is graded in Cormack-Lehane Scale by the laryngoscopist.
Grade I is assigned when the glottis is fully visible, grade II when the glottis is partially visible, grade III when only the epiglottis is visible and grade IV when neither glottis nor epiglottis is visible.
|
Preoperative (1 day prior to the operation)
|
Thyromental distance
Tidsramme: Preoperative (1 day prior to the operation)
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The distance between the thyroid prominence and the most anterior part of the mental prominence of the mandible, measured with a standard centigrade ruler as the distance in centimetres with the patient in supine position, head fully extended, mouth closed, during routine preoperative anaesthetic visit.
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Preoperative (1 day prior to the operation)
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Sternomental distance
Tidsramme: Preoperative (1 day prior to the operation)
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The distance in centimetres between the superior border of the manubrium sterni and the bony point of the mentum, with the patient in supine position, head fully extended, mouth closed, measured with a standard centigrade ruler, during routine preoperative anaesthetic visit.
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Preoperative (1 day prior to the operation)
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score in modified Mallampati test
Tidsramme: Preoperative (1 day prior to the operation)
|
The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.
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Preoperative (1 day prior to the operation)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Hanna Misiołek, MD PhD, Medical University of Silesia
- Studiestol: Szymon Białka, MD, Medical University of Silesia
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.
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)
1. juni 2019
Primær færdiggørelse (Faktiske)
1. oktober 2019
Studieafslutning (Faktiske)
1. oktober 2019
Datoer for studieregistrering
Først indsendt
22. september 2019
Først indsendt, der opfyldte QC-kriterier
22. september 2019
Først opslået (Faktiske)
24. september 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. april 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. april 2020
Sidst verificeret
1. april 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- TMHT-04
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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