- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07820319
The Use of Single-Beat TE-e' in Evaluation of Left Atrial Pressure in Critically Ill Patients: The TELAP-ICU Trial (TELAP-ICU)
9. september 2026 opdateret af: Wincy Wing-Sze Ng, Queen Mary Hospital, Hong Kong
This study evaluates a new single-beat echocardiographic technique (TE-e', the time difference between the onset of the mitral inflow E wave and the septal e' wave on tissue Doppler imaging) for estimating left atrial pressure (LAP) in critically ill patients, comparing it against the standard two-beat method.
The goal is to determine whether the faster, single-beat method gives results as reliable as the conventional method, and whether it can help identify patients with elevated left atrial pressure without an invasive procedure.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Left atrial pressure (LAP) is an important measure in the care of critically ill patients but usually requires an invasive catheter to assess directly.
Echocardiography offers a non-invasive alternative.
One promising marker, TE-e' (the time difference between the onset of the mitral inflow E wave and the septal e' wave on tissue Doppler imaging), was recently incorporated into the 2025 American Society of Echocardiography (ASE) diastolic function guidelines.
The conventional method for calculating TE-e' requires measurements from two separate heartbeats, introducing potential error from beat-to-beat heart rate variability - a common issue in the critically ill patients.
This study assesses a novel single-beat method, in which both waveforms are captured on the same Doppler display within one cardiac cycle, eliminating that source of variability.
Patients undergoing clinically indicated transthoracic echocardiography (TTE) in the Adult Intensive Care Unit of Queen Mary Hospital, Hong Kong will have TE-e' measured by both methods, along with other echocardiographic parameters associated with LAP, to evaluate correlation between the two methods and their relationship with clinically assessed LAP.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
50
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wincy Ng, MBBS
- Telefonnummer: 22551331
- E-mail: wincyngwingsze@gmail.com
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Rekruttering
- Adult Intensive Care Unit, Queen Mary Hospital
-
Kontakt:
- Wincy Ng, MBBS
- Telefonnummer: 22551331
- E-mail: wincyngwingsze@gmail.com
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients admitted to Adult Intensive Care Unit requiring a TTE
Beskrivelse
Inclusion Criteria:
- Adult patients ≥18 years admitted to the QMH Adult Intensive Care Unit (AICU)
- Requiring a transthoracic echocardiogram (TTE) as part of routine clinical care
- TE-e' obtainable by both the conventional and the novel method
Exclusion Criteria:
- Patients <18 years of age
- Patients in atrial fibrillation
- Patients with a poor TTE acoustic window
- Patients in whom TE-e' is technically difficult to obtain or interpret by either method
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 |
|---|---|
|
Single cohort
each patient serves as their own comparison - conventional vs. novel method measured within the same transthoracic echocardiography study
|
Full echocardiogram performed on recruited patients.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Correlation between novel (single-beat) and conventional (two-beat) TE-e' values
Tidsramme: At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Correlation between novel and conventional methods in obtaining septal e' and s' velocities - At time of index TTE
Tidsramme: At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
|
Correlation between clinical evaluation of LAP and TE-e' value
Tidsramme: At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
|
Correlation between other echocardiographic parameters of LAP (E/A ratio, LAVi, TR Vmax, lung ultrasound 6-point protocol) and TE-e' value
Tidsramme: At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
At the time of index TTE (single time point for each patient) during the course of ICU stay (from day 1 of ICU admission till ICU discharge, up to 1 month)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. juli 2026
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
30. juni 2027
Datoer for studieregistrering
Først indsendt
1. september 2026
Først indsendt, der opfyldte QC-kriterier
9. september 2026
Først opslået (Faktiske)
15. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Patologiske processer
- Hjertesygdomme
- Sygdomsegenskaber
- Ventrikulær dysfunktion
- Patologiske tilstande, tegn og symptomer
- Kritisk sygdom
- Ventrikulær dysfunktion, venstre
- Diagnostiske teknikker og procedurer
- Diagnose
- Diagnostisk billeddannelse
- Diagnostiske teknikker, kardiovaskulær
- Hjertefunktionstest
- Hjertebillede -teknikker
- Ultrasonografi
- Ekkokardiografi
Andre undersøgelses-id-numre
- UW 26-246
Plan for individuelle deltagerdata (IPD)
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