- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04101734
TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes
26 april 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
60
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Silesia
-
Zabrze, Silesia, Polen, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Consecutive patients undergoing elective thoracic procedures in university hospital, requiring general anaesthesia and intubation with a double lumen endotracheal tubes.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Double Lumen Endotracheal Tube
Group of patients intubated with Double Lumen Endotracheal Tube.
|
Intubation was performed with Double Lumen Endotracheal Tube.
|
|
Double Lumen Video Endotracheal Tube
Group of patients intubated with Double Lumen Video Endotracheal Tube.
|
Intubation was performed with Double Lumen Video Endotracheal Tube.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Thyromental height
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time of Intubation
Tidsram: 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
|
|
Airway trauma
Tidsram: 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.
|
Intraoperative
|
|
Usage of fiberoptic bronchoscopy
Tidsram: Intraoperatively
|
Usage of fiberoptic bronchoscopy for proper placement of double lumen tube was noted.
|
Intraoperatively
|
|
score in Cormack-Lehane scale
Tidsram: 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
Tidsram: Preoperative (1 day prior to the operation)
|
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.
|
Preoperative (1 day prior to the operation)
|
|
Sternomental distance
Tidsram: Preoperative (1 day prior to the operation)
|
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.
|
Preoperative (1 day prior to the operation)
|
|
score in modified Mallampati test
Tidsram: 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.
|
Preoperative (1 day prior to the operation)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Hanna Misiołek, MD PhD, Medical University of Silesia
- Studiestol: Szymon Białka, MD, Medical University of Silesia
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2019
Primärt slutförande (Faktisk)
1 oktober 2019
Avslutad studie (Faktisk)
1 oktober 2019
Studieregistreringsdatum
Först inskickad
22 september 2019
Först inskickad som uppfyllde QC-kriterierna
22 september 2019
Första postat (Faktisk)
24 september 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 april 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 april 2020
Senast verifierad
1 april 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- TMHT-04
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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