ClinicalTrials.gg
CompletedNCT07794917TAU-LHUpdated Aug 31, 2026

Trendelenburg Angle and Upper Airway Ultrasound Findings in Laparoscopic Hysterectomy

An observational study in Upper Airway Edema, Postextubation Stridor and Laparoscopic Hysterectomy, sponsored by Izmir City Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Izmir City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
68
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 80 studies in Edema with a site in Turkey — 11 open to participants now, 15 under way, 1 of them phase 3. Edema · Turkey.

Enrollment
8th of 18
68 · median 62
Started
2026
with 4 others
Observational
18 of 80
4 open now
Registered
78th of 80
by date

Among the 80 studies in Edema with a site in Turkey, this one is the 8th largest by enrollment of the 18 observational ones that give a count, is one of 5 that started in 2026, is one of 18 observational ones, and was the 78th registered.

Edema

566 studies on the registry are indexed under Edema; 95 are open to participants now.

This study's enrollment of 68 is close to the median of 67 across 143 observational studies indexed under Edema.

Browse Edema studies →

Open to participants now

11 of the 80 studies in Edema with a site in Turkey are open now, in 12 countries. Each count lists the studies.

All 11 open studies →

Who these studies take

Of the 56 Edema studies recruiting now, 34 (61%) set no upper age limit and 16 (29%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.

This study: 18 Years to 65 Years · female · no healthy volunteers.

The full table on the hub →
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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Upper Airway Edema
  • Postextubation Stridor
  • Laparoscopic Hysterectomy

Keywords

  • Trendelenburg Position
  • Laparoscopic Hysterectomy
  • Airway Ultrasonography
  • Upper Airway Edema
  • Postextubation Stridor
  • Postoperative Airway Findings
  • General Anesthesia
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

  • Female patients aged 18 to 65 years
  • Scheduled for elective laparoscopic hysterectomy
  • Planned surgery under general anesthesia
  • physical status I to III
  • 35 kg/m² or lower
  • Provided written 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 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:

-

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
68 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Trendelenburg positioning during laparoscopic hysterectomy

Interventions

  • OtherTrendelenburg 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.

06

What researchers measure

Primary outcomes

  1. Change in distance from skin to epiglottis

    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.

    Time frame: From before anesthesia induction to the end of surgery before return to the supine position

Secondary outcomes

  1. Change in tongue thickness

    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.

    Time frame: From before anesthesia induction to the end of surgery before return to the supine position

07

Study locations

1 site
  • Izmir City Hospital
    Izmir, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

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

Access criteria: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in May 2026, 3 months.

Of 76 non-industry observational studies under Edema, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 3 months is below that.

Counting every sponsor, half of 85 studies reached it within 23 months; a quarter within 7 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Aug 31, 2026
StartActual
Feb 5, 2026
Primary completionActual
May 5, 2026
CompletionActual
May 5, 2026
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07794917
Lead sponsor
Izmir City Hospital
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Feb 5, 2026
Primary completion
May 5, 2026
Completion
May 5, 2026
Last update
Aug 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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