- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07794917
Trendelenburg Angle and Upper Airway Ultrasound Findings in Laparoscopic Hysterectomy (TAU-LH)
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Izmir, Turcja (Türkiye)
- İzmir City Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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:
-
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in distance from skin to epiglottis
Ramy czasowe: 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.
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From before anesthesia induction to the end of surgery before return to the supine position
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in tongue thickness
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- IZMIR-USG-TREND-2026-57
- 2026/57 (Identyfikator rejestru: Izmir City Hospital Non-Interventional Clinical Research Ethics Committee)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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