NCT07628868

Brief Summary

In this preoperative observational study, the effect of preoperative ultrasonographic measurements on the success of videolaryngoscopy in predicting difficult airways was investigated; furthermore, the aim was to determine new cut-off values that can predict difficult intubation in videolaryngoscope use. In our study, it was tested that the use of videolaryngoscope significantly increased the success of intubation in patients who were assessed as having difficult airways with upper airway ultrasound measurements.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 21, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

December 15, 2025

Last Update Submit

June 1, 2026

Conditions

Keywords

Difficult airwayUltrasonographyDifficult laryngoscopyDifficult mask ventilation

Outcome Measures

Primary Outcomes (1)

  • Difficult videolaryngoscopic intubation

    Difficult videolaryngoscopic intubation will be assessed using the VIDIAC score, a scoring system specifically developed to quantify intubation difficulty during videolaryngoscopy.

    During videolaryngoscopy (periprocedural)

Secondary Outcomes (1)

  • Difficult mask ventilation

    During ventilation (periprocedural)

Study Arms (1)

None (Orotracheal intubation will be performed using a videolaryngoscope in all patients)

Patients aged 18 years and older, classified as American Society of Anesthesiologists (ASA) physical status I-III, who will undergo surgery under general anesthesia requiring orotracheal intubation, will be included in this prospective observational study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation

You may qualify if:

  • Patients aged 18 years and older
  • Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (ASA I-III)

You may not qualify if:

  • Patients undergoing surgery under sedation or regional anesthesia
  • Patients not planned for endotracheal intubation
  • Patients with a history of difficult airway
  • Patients with an acute respiratory tract infection
  • Patients with congenital or acquired upper airway anomalies
  • Patients with facial or maxillofacial tumors or fractures
  • Patients with cervical spine fracture
  • Patients with a history of cervical or craniofacial radiotherapy
  • Patients with a tracheostomy
  • Pregnant patients
  • Patients who do not meet the required fasting period or who refuse to -participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, Bakirköy, 34147, Turkey (Türkiye)

Location

Related Publications (5)

  • Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.

    PMID: 25403231BACKGROUND
  • Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007.

    PMID: 17065880BACKGROUND
  • Gomes SH, Simoes AM, Nunes AM, Pereira MV, Teoh WH, Costa PS, Kristensen MS, Teixeira PM, Pego JM. Useful Ultrasonographic Parameters to Predict Difficult Laryngoscopy and Difficult Tracheal Intubation-A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 28;8:671658. doi: 10.3389/fmed.2021.671658. eCollection 2021.

    PMID: 34124099BACKGROUND
  • Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87.

    PMID: 19293691BACKGROUND
  • Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.

    PMID: 34762729BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

December 15, 2025

First Posted

June 5, 2026

Study Start

December 21, 2025

Primary Completion

June 10, 2026

Study Completion

July 20, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study contains personal health information and no regulatory or ethics approval has been obtained for external data sharing.

Locations