- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03394872
Impact of Draining Significant Effusion on Gas Exchange and Lung Mechanics in Patient Under Mechanical Ventilation
8. januar 2018 opdateret af: Begum Ergan, Dokuz Eylul University
Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator support, had significant pleural effusion (both transudates and exudates) and drainage plan were evaluated.
Decision to drain, timing and duration of drainage were made by primary physician according to the intensive care unit (ICU) protocols.The estimated amount of effusion (mL) was calculated as the maximum pleura-lung distance (mm) x 20 and significant effusion is accepted as ≥ 800 mL according to thoracic ultrasonography (USG) performed by the intensivist.
The amount of effusion drained, mechanical ventilator parameters, arterial blood gas results and hemodynamic data were recorded before, at the 1st hour and at the end of drainage up to 30 days after drainage.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
27
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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Critical care patients on mechanical ventilation due to acute respiratory failure and have significant pleural effusion who had drainage plan according to İCU protocols decided by primary physician were enrolled for the study
Beskrivelse
Inclusion Criteria:
- Patients on mechanical ventilation due to acute respiratory failure
- Estimated effusion > 800 ml according to USG
- Have drainage plan according to ICU protocols decided by primary physician
Exclusion Criteria:
- Have absolute drainage indication (empyema, hemothorax or chylothorax)
- predicted duration of mechanical ventilation less than 72 hours
- contraindications to drainage,
- underlying disease, which prevents lung expansion (chest deformity, central atelectasis)
- malignant effusions
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 |
---|---|
Drainage group
Patients under mechanical ventilator support due to acute respiratory failure who had significant pleural effusion and drainage plan according to the intensive Care Unit (ICU) protocols decided by primary physician
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Correlation between estimated and drained effusion volume
Tidsramme: 1- Estimated effusion volume just before the drainage (by ultrasonography calculated as described in brief summary) 2- Drained effusion volume just after the drainage is terminated up to 30 days after procedure.
|
Volume of the effusion estimated and drained was recorded (mL)
|
1- Estimated effusion volume just before the drainage (by ultrasonography calculated as described in brief summary) 2- Drained effusion volume just after the drainage is terminated up to 30 days after procedure.
|
Change in Lung mechanics
Tidsramme: 1- Dynamic Compliance just before the drainage 2- Dynamic Compliance just after the drainage is terminated up to 30 days after procedure
|
Dynamic Compliance (mL/cmH2O)
|
1- Dynamic Compliance just before the drainage 2- Dynamic Compliance just after the drainage is terminated up to 30 days after procedure
|
Change in Oxygenation
Tidsramme: 1- PaO2/FiO2 just before the drainage 2- PaO2/FiO2 just after the drainage is terminated up to 30 days after procedure
|
PaO2/FiO2 (fraction of inspired oxygen)
|
1- PaO2/FiO2 just before the drainage 2- PaO2/FiO2 just after the drainage is terminated up to 30 days after procedure
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Barış Yılmaz, MD, Fellow of Critical Care in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
- Studiestol: Tuğçe Yılmaz, MD, Fellow of Critical Care in Department of Neurology and Critical Care Medicine in Dokuz Eylül University
- Ledende efterforsker: Begum Ergan, MD, Staff in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
- Studieleder: Necati Gokmen, MD, Staff in Department of Anesthesiology and Critical Care Medicine in Dokuz Eylül University
- Studiestol: Kutlay Aydin, MD, Fellow of Critical Care in Department of Anesthsiology and Critical Care Medicine in Dokuz Eylül University
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. maj 2016
Primær færdiggørelse (Faktiske)
30. august 2017
Studieafslutning (Faktiske)
30. august 2017
Datoer for studieregistrering
Først indsendt
19. december 2017
Først indsendt, der opfyldte QC-kriterier
8. januar 2018
Først opslået (Faktiske)
9. januar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2496-GOA
Plan for individuelle deltagerdata (IPD)
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INGEN
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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 .
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