Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Trendelenburg Angle and Upper Airway Ultrasound Findings in Laparoscopic Hysterectomy (TAU-LH)

27. august 2026 opdateret af: Izmir City Hospital

Evaluation of the Effect of Trendelenburg Position on Upper Airway Edema by Ultrasonography and Its Relationship With Postoperative Clinical Airway Findings in Patients Undergoing Laparoscopic Hysterectomy

This observational study was designed to evaluate whether the Trendelenburg position used during laparoscopic hysterectomy is associated with swelling of the upper airway.

Women scheduled for elective laparoscopic hysterectomy under general anesthesia were included. During surgery, the angle of the operating table in the Trendelenburg position was measured. The upper airway was assessed with bedside ultrasound by measuring the distance from the skin to the epiglottis and the thickness of the tongue at different time points before and during surgery.

The study did not assign participants to any treatment or intervention. All participants received standard surgical and anesthetic care. After surgery, participants were monitored for early airway-related findings such as noisy breathing after extubation, need for extra oxygen, low oxygen saturation, or need for reintubation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Laparoscopic hysterectomy often requires carbon dioxide pneumoperitoneum and Trendelenburg positioning to improve surgical exposure. This position may shift fluid toward the head and neck region and may contribute to swelling of upper airway soft tissues.

This single-center prospective observational study included adult female participants scheduled for elective laparoscopic hysterectomy under general anesthesia. No study-related intervention was assigned. The Trendelenburg angle was determined by the surgical team according to routine clinical need and was recorded using a digital inclinometer.

Upper airway ultrasound measurements were performed at three perioperative time points: before anesthesia induction in the supine position, after Trendelenburg positioning, and at the end of surgery before return to the supine position. The measured ultrasound parameters were distance from skin to epiglottis and tongue thickness.

After extubation, participants were monitored in the post-anesthesia care unit and during the first 24 postoperative hours for clinical airway findings, including postextubation stridor, supplemental oxygen requirement, oxygen saturation below 94% on room air, and reintubation. The study aimed to assess the relationship between Trendelenburg angle, ultrasound-measured upper airway soft tissue changes, and early postoperative clinical airway findings.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

68

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Adult female patients scheduled for elective laparoscopic hysterectomy under general anesthesia at Izmir City Hospital, University of Health Sciences, Izmir, Turkey.

Beskrivelse

Inclusion Criteria:

  • Female patients aged 18 to 65 years
  • Scheduled for elective laparoscopic hysterectomy
  • Planned surgery under general anesthesia
  • American Society of Anesthesiologists physical status I to III
  • Body mass index 35 kg/m² or lower
  • Provided written informed consent for study participation

Exclusion Criteria:

  • Known history of difficult airway or expected difficult airway on preoperative evaluation
  • Mallampati class III or IV
  • Congenital or acquired upper airway pathology
  • Neck mass or previous neck surgery
  • Body mass index greater than 35 kg/m²
  • Pregnancy
  • Emergency surgery
  • Known chronic respiratory disease, such as chronic obstructive pulmonary disease or advanced asthma
  • Upper respiratory tract infection within the previous three weeks
  • Inability to communicate in Turkish
  • Lack of cooperation
  • Conversion to open surgery
  • Requirement for blood transfusion or additional fluid resuscitation beyond the standard protocol
  • Significant hypotension requiring vasopressor support
  • Persistent high peak airway pressures with ventilatory difficulty
  • More than two intubation attempts
  • Withdrawal from the study

Exclusion Criteria:

-

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
Laparoscopic Hysterectomy Cohort
Adult female participants scheduled for elective laparoscopic hysterectomy under general anesthesia. Participants received standard surgical and anesthetic care. No study-related intervention was assigned. Trendelenburg angle was determined according to routine surgical need and recorded during surgery. Upper airway ultrasound measurements were obtained perioperatively, and participants were monitored for postoperative clinical airway findings during the first 24 hours.
Andet: Trendelenburg positioning during laparoscopic hysterectomy
Participants underwent elective laparoscopic hysterectomy under general anesthesia as part of standard clinical care. Trendelenburg positioning was applied according to routine surgical need and was not assigned by the study protocol. The Trendelenburg angle was measured and recorded during surgery. Upper airway ultrasound measurements were obtained before and during surgery, and participants were monitored for postoperative clinical airway findings during the first 24 hours.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in distance from skin to epiglottis
Tidsramme: From before anesthesia induction to the end of surgery before return to the supine position
Distance from skin to epiglottis was measured using point-of-care upper airway ultrasonography before anesthesia induction, after Trendelenburg positioning, and at the end of surgery before return to the supine position. The outcome was the change from baseline to the end of surgery, expressed in centimeters.
From before anesthesia induction to the end of surgery before return to the supine position

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in tongue thickness
Tidsramme: From before anesthesia induction to the end of surgery before return to the supine position
Tongue thickness was measured using point-of-care upper airway ultrasonography before anesthesia induction, after Trendelenburg positioning, and at the end of surgery before return to the supine position. The outcome was the change in tongue thickness from baseline to the end of surgery, expressed in centimeters.
From before anesthesia induction to the end of surgery before return to the supine position

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Izmir City Hospital

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)

5. februar 2026

Primær færdiggørelse (Faktiske)

5. maj 2026

Studieafslutning (Faktiske)

5. maj 2026

Datoer for studieregistrering

Først indsendt

27. august 2026

Først indsendt, der opfyldte QC-kriterier

27. august 2026

Først opslået (Faktiske)

31. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IZMIR-USG-TREND-2026-57
  • 2026/57 (Registry Identifier: Izmir City Hospital Non-Interventional Clinical Research Ethics Committee)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in this study may be shared upon reasonable request. Shared data will not include any direct personal identifiers. Access will be subject to approval by the corresponding author and applicable institutional and ethics committee requirements.

IPD-delingstidsramme

Data may become available after publication of the main study results and may be available for 5 years after publication.

IPD-delingsadgangskriterier

Data may be made available to qualified researchers who submit a methodologically sound proposal for scientific purposes related to perioperative airway management, airway ultrasonography, or postoperative airway outcomes. Requests should be directed to the corresponding author. Data sharing will require appropriate institutional and ethics committee approval when applicable.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Abonner