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

27. august 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

68

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Izmir City Hospital

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)

5. februar 2026

Primær fullføring (Faktiske)

5. mai 2026

Studiet fullført (Faktiske)

5. mai 2026

Datoer for studieregistrering

Først innsendt

27. august 2026

Først innsendt som oppfylte QC-kriteriene

27. august 2026

Først lagt ut (Faktiske)

31. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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