NCT06457165

Brief Summary

Prediction of difficult preoperative intubation in obese patients and completion of preparations for difficult intubation both reduce the risk of repeated intubation and prevent complications. In this study, the investigators aimed to evaluate whether anthropometric measurements are superior in defining difficult preoperative airways.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 10, 2024

Last Update Submit

June 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suprasternal Adipose Tissue Thickness

    It is predicted that it may indicate difficult intubation.

    within 10 minutes before going into surgery

Secondary Outcomes (13)

  • Abdominal circumference

    within 10 minutes before going into surgery

  • Waist circumference

    within 10 minutes before going into surgery

  • Arm circumference

    within 10 minutes before going into surgery

  • Distance between incisions

    within 10 minutes before going into surgery

  • Thyromental distance measurement

    within 10 minutes before going into surgery

  • +8 more secondary outcomes

Study Arms (2)

Difficult Intubation

Abdominal circumference, waist circumference, arm circumference, distance between incisions,TMD and SMD measurements, Mallampati test, Wilson score, and suprasternal subcutaneous adipose tissue thickness were measured and recorded. ECG, SBP and DBP, and SpO2 monitoring were performed. Pre-oxygenation was performed using a 100% oxygen face mask for 3 min before the induction of anesthesia. Induction of anesthesia was achieved with IV 1 mg/kg lidocaine, 0.125 mcgr/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. After 2 min of adequate muscle relaxation, the patient was intubated with an endotracheal tube of appropriate diameter. Cormack-Lehane score was evaluated during laryngoscopy. Patients with more than 3 intubation attempts by an experienced anesthesiologist were considered difficult to intubate. In maintenance, 0.1 mcg/kg/h remifentanil was administered in sevoflurane O2-air mixture. Age, sex, body weight,BMI, and ASA scores were recorded.

Device: Difficult IntubationDevice: Not Difficult Intubation

Not Difficult Intubation

Abdominal circumference, waist circumference, arm circumference, distance between incisions,TMD and SMD measurements, Mallampati test, Wilson score, and suprasternal subcutaneous adipose tissue thickness were measured and recorded. ECG, SBP and DBP, and SpO2 monitoring were performed. Pre-oxygenation was performed using a 100% oxygen face mask for 3 min before the induction of anesthesia. Induction of anesthesia was achieved with IV 1 mg/kg lidocaine, 0.125 mcgr/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. After 2 min of adequate muscle relaxation, the patient was intubated with an endotracheal tube of appropriate diameter. Cormack-Lehane score was evaluated during laryngoscopy. Patients with more than 3 intubation attempts by an experienced anesthesiologist were considered difficult to intubate. In maintenance, 0.1 mcg/kg/h remifentanil was administered in sevoflurane O2-air mixture. Age, sex, body weight,BMI, and ASA scores were recorded.

Device: Difficult IntubationDevice: Not Difficult Intubation

Interventions

Noted for each patient.

Also known as: Age, ASA, BMI, Arm circumference, TMD, SMD, Distance between incisions, Abdominal circumference, Waist circumference, Suprasternal adipose tissue thickness, Mallampati, Cormack-Lehane score, Wilson score
Difficult IntubationNot Difficult Intubation

Noted for each patient.

Also known as: Age, ASA, BMI, Arm circumference, TMD, SMD, Distance between incisions, Abdominal circumference, Waist circumference, Suprasternal adipose tissue thickness, Mallampati, Cormack-Lehane score, Wilson score
Difficult IntubationNot Difficult Intubation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

40 patients between the ages of 18-60 years, ASA 1-3, BMI ≥30 kg/m2, ASA 1-3, scheduled for elective abdominal surgery under general anesthesia.

You may qualify if:

  • years
  • ASA 1-3
  • BMI ≥30 kg/m2
  • ASA 1-3
  • Scheduled for elective abdominal surgery under general anesthesia

You may not qualify if:

  • \<18 and \>60 years
  • ASA\>3
  • BMI\<30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

Waist Circumference

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body SizeBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological Phenomena

Study Officials

  • Ayça Tuba Dumanlı Özcan

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. MD

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations