NCT07297420

Brief Summary

This study aims to compare the incidence and characteristics of peri-intubation adverse airway events in critically ill trauma patients with morbid obesity versus those with super obesity, and to determine whether increasing BMI independently predicts severe peri-intubation complications.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet 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

Study Progress22%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

November 24, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

November 24, 2025

Last Update Submit

April 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Severe hypoxemia

    SpO₂ \<80% during intubation

    30 minutes

Secondary Outcomes (2)

  • Major peri-intubation complications

    30 minutes

  • hospital mortality

    28 days

Study Arms (2)

Group 1

Morbidly obese (BMI 40-49.9 kg/m²)

Procedure: endotracheal intubation

Group 2

Super obese (BMI ≥50 kg/m²)

Procedure: endotracheal intubation

Interventions

adult trauma patients (≥18 years) admitted to the Surgical Intensive Care Unit

Group 1Group 2

Eligibility Criteria

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

Critically ill adult trauma patients aged 18 years and older admitted to the surgical ICU at UF Health Jacksonville between January 1, 2023, and November 1, 2025, who had a BMI ≥40 kg/m² and underwent intubation

You may qualify if:

  • Age ≥ 18 years
  • BMI ≥40
  • Admission to the surgical ICU and intubated during ICU stay
  • Availability of complete clinical data

You may not qualify if:

  • Age \< 18 years
  • BMI\<40
  • No intubation
  • Incomplete or missing medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Ayten SARAÇOĞLU, Prof,MD

    Florida University Jacksonville

    STUDY DIRECTOR

Central Study Contacts

Ayten SARAÇOĞLU, Prof,MD

CONTACT

Tolga SARAÇOĞLU, Prof,MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Anesthesiology and Reanimation department,Assoc Prof

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 22, 2025

Study Start

April 23, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share