CT-Guided vs Conventional DLT Sizing in Thoracic Surgery (CTDLT-SIZE)
4. august 2026 oppdatert av: King Hussein Cancer Center
CT-Guided Versus Traditional Selection of Double-Lumen Tube Size for One-Lung Ventilation in Thoracic Surgery: A Prospective Study
This is a prospective, randomized, single-blinded controlled trial designed to compare CT-guided versus conventional methods for selecting double-lumen tube (DLT) size in patients undergoing thoracic surgery requiring one-lung ventilation
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a prospective, randomized, single-blinded controlled trial designed to compare CT-guided versus conventional methods for selecting double-lumen tube (DLT) size in patients undergoing thoracic surgery requiring one-lung ventilation. The study aims to evaluate whether preoperative computed tomography (CT)-based bronchial diameter measurement improves the accuracy of initial DLT size selection compared with conventional selection based on demographic parameters.
Eligible patients will be randomly assigned in a 1:1 ratio to either the CT-guided group or the conventional group.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Moh'D Yousef, Consultant
- Telefonnummer: +962796420055
- E-post: MY.16674@KHCC.JO
Studer Kontakt Backup
- Navn: Ahmad Al Kharabsheh, Fellow physician
- Telefonnummer: 00962-796420055
- E-post: AA.15386@KHCC.JO
Studiesteder
-
-
-
Amman, Jordan, 11941
- Rekruttering
- King Hussein Cancer Center
-
Ta kontakt med:
- Ahmad Al Kharabsheh, Fellow physician
- Telefonnummer: 00962-796420055
- E-post: AA.15386@KHCC.JO
-
Ta kontakt med:
- Moh'D Yousef, MD
- Telefonnummer: +962796420055
- E-post: MY.16674@KHCC.JO
-
Hovedetterforsker:
- Dr. Moh'd Yousef, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Adult patients (≥18 years) scheduled for elective thoracic surgery requiring one-lung ventilation.
- Availability of preoperative thoracic CT imaging.
- Procedures requiring placement of a left-sided DLT.
- Patient who has a normal pulmonary function test.
Exclusion Criteria:
- Previous tracheal surgery
- Patient with difficult airway whom need bronchial blocker.
- Emergency thoracic procedures.
- Incomplete intraoperative or imaging data.
- Patient with severe obstruction or restriction.
- Pediatric patient
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: CT-Guided Group
Participants will undergo preoperative CT measurement of the bronchial diameter 10 mm distal to the carina.
DLT size will be selected using manufacturer-recommended correlation charts based on CT measurements.
|
Participants will undergo preoperative CT measurement of the bronchial diameter 10 mm distal to the carina.
DLT size will be selected using manufacturer-recommended correlation charts based on CT measurements.
|
|
Aktiv komparator: Conventional Group
DLT size will be selected using standard clinical criteria based on patient demographics, according to institutional standard tables.
|
DLT size will be selected using standard clinical criteria based on patient demographics, including sex, height, and weight, according to institutional standard tables.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful selection of the correct DLT size on the first attempt (defined as optimal position and lung isolation without the need for tube exchange) using fiberoptic scope
Tidsramme: During the intraoperative period (at first attempt of double-lumen tube placement)
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the correct placement of a double-lumen tube (DLT) on the first attempt, achieving optimal tracheobronchial position and effective lung isolation as confirmed by fiberoptic bronchoscopy, without the need for tube exchange or repositioning.
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During the intraoperative period (at first attempt of double-lumen tube placement)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of DLT replacement
Tidsramme: Intraoperative period (from initial DLT placement until end of surgery)
|
Number of participants requiring replacement of the double-lumen tube (DLT) after initial placement due to incorrect size, malposition, or inadequate lung isolation
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Intraoperative period (from initial DLT placement until end of surgery)
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Time required for successful intubation
Tidsramme: Intraoperative period (from DLT insertion to confirmed successful placement)
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Time (in seconds) from insertion of the double-lumen tube into the mouth until successful tracheal placement and confirmation of correct positioning and lung isolation
|
Intraoperative period (from DLT insertion to confirmed successful placement)
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Frequency of intraoperative hypoxia and peak airway pressure fluctuations
Tidsramme: Intraoperative period (from DLT insertion to confirmed successful placement)
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Incidence of episodes of intraoperative hypoxia and measurement of peak airway pressure fluctuations during one-lung ventilation.
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Intraoperative period (from DLT insertion to confirmed successful placement)
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Blinded assessment of surgeon satisfaction (lung isolation quality)
Tidsramme: At the end of surgery (intraoperative assessment)
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Surgeon satisfaction with lung isolation quality assessed using a standardized scoring scale, evaluated in a blinded manner at the end of the surgical procedure.
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At the end of surgery (intraoperative assessment)
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Post-operative sore throat or airway trauma
Tidsramme: 24 hours post-extubation
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Incidence and severity of post-operative sore throat and/or signs of airway trauma (e.g., hoarseness, blood on suctioning, or mucosal injury if assessed) within 24 hours after extubation.
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24 hours post-extubation
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Moh'D Yousef, Consultant, Anesthesiology, King Hussein Cancer Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. mai 2026
Primær fullføring (Antatt)
2. mai 2028
Studiet fullført (Antatt)
1. august 2028
Datoer for studieregistrering
Først innsendt
4. mai 2026
Først innsendt som oppfylte QC-kriteriene
4. mai 2026
Først lagt ut (Faktiske)
8. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26 KHCC 59
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