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ObesityNCT07297420

Peri-Intubation Adverse Airway Events in Critically Ill Patients With Morbid and Super Obesity

An observational study of Obesity and Airway Complication of Anesthesia, run by Zeliha Alicikus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
endotracheal intubation
Type of treatment
Surgery or procedure
How many people
223 participants
Where
1 siteUnited States
Study dates
23 Apr 2026to 30 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UF Health Jacksonville (Shands Hospital)

    Jacksonville, Florida, 32218

Other trials in United States

About this study

Official title: Peri-Intubation Adverse Airway Events in Critically Ill Patients With Morbid and Super Obesity: A Retrospective Analysis

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.

Read the detailed description

Obesity represents a major global health challenge, with prevalence steadily rising worldwide. Beyond its well-characterized metabolic and cardiovascular consequences, obesity poses significant challenges for airway management, particularly among critically ill patients requiring urgent tracheal intubation. The degree of obesity is clinically relevant: morbid obesity (BMI ≥40 kg/m²) is associated with anatomical and physiological alterations that markedly increase the risk of difficult airway and peri-intubation complications compared with patients with BMI <40 kg/m².

From an anatomical perspective, morbidly obese patients often present with a short, thick neck, increased cervical adiposity, and limited atlanto-occipital extension, complicating optimal positioning and glottic visualization during laryngoscopy. Redundant upper airway soft tissue, macroglossia, and higher Mallampati classes further impede mask ventilation and reduce pharyngeal patency. Secondary analyses of the international INTUBE cohort demonstrated that obese critically ill patients had a significantly higher prevalence of difficult airway predictors such as short neck, reduced mouth opening, and high Mallampati scores, compared with non-obese patients (74.3% - 35.7%, p<0.001). Similarly, in a large retrospective bariatric cohort, severe obesity independently increased the odds of difficult intubation when Cormack-Lehane grade IV (OR 8.9) or Mallampati IV (OR 5.1) were present.

Physiological derangements further compound these challenges. Elevated intra-abdominal pressure and cephalad diaphragm displacement reduce functional residual capacity (FRC) and expiratory reserve volume, leaving critically limited oxygen reserves during apnea. Increased oxygen consumption and basal metabolic rate shorten the safe apneic window, resulting in rapid desaturation if intubation is prolonged or requires multiple attempts. The INTUBE study reported that severe peri-intubation hypoxemia (SpO₂ <80%) occurred more frequently in obese versus non-obese critically ill patients (12.1% - 8.6%, p=0.01), and first-pass intubation failure strongly correlated with this complication. Even in optimized elective settings such as bariatric surgery, BMI >60 kg/m² significantly increased the risk of difficult intubation, despite high first-pass success rates (95.4%) and low complication rates.

These findings highlight that morbid obesity imposes both anatomical and physiological barriers to safe intubation. Critically ill patients with morbid obesity are uniquely vulnerable, with increased risks of failed first-pass attempts, severe hypoxemia, and potentially life-threatening complications. However, prospective evidence directly comparing peri-intubation outcomes among critically ill patients with BMI 40-50 versus ≥50 kg/m² remains limited.

While morbid obesity is an established risk factor, there is a compelling physiological rationale to suspect heterogeneity of risk within this category. Super obesity (BMI ≥50 kg/m²) may represent a distinct phenotype with more pronounced anatomical and physiological derangements. In elective bariatric populations, BMI >50 kg/m² has been linked to difficult mask ventilation and intubation, suggesting a threshold effect for extreme obesity [6]. Potential mechanisms include increased fat deposition in the neck and pharynx, further reductions in FRC, and higher prevalence of comorbidities such as obesity hypoventilation syndrome. Nonetheless, studies in elective settings remain inconclusive; for example, Mahmoud et al. found that neither super-obesity nor super-super-obesity independently predicted difficult intubation or mask ventilation, with high STOP-Bang and Mallampati scores emerging as the primary predictors.

Critically ill patients differ substantially from elective surgical populations, presenting with limited FRC, rapid desaturation during apnea, hemodynamic instability, and multiple comorbidities, which may amplify the impact of morbid and super obesity on peri-intubation outcomes. Consequently, the independent effect of BMI ≥40 kg/m² on peri-intubation complications in the ICU remains uncertain.

To address this knowledge gap, the present study was designed as the first investigation in the literature to directly compare peri-intubation adverse events between morbidly obese and super obese critically ill trauma patients.The partipicants hypothesize that super obese patients experience a higher incidence of severe peri-intubation complications compared with their morbidly obese counterparts, thereby providing novel insight into risk stratification and airway management in this high-risk population.

Being tested
endotracheal intubation
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endotracheal intubationProcedure or surgery

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

Study groups in NCT07297420
Study groupRoleWhat they receive
Group 1Morbidly obese (BMI 40-49.9 kg/m²)
Receives: Procedure: endotracheal intubation
Group 2Super obese (BMI ≥50 kg/m²)
Receives: Procedure: endotracheal intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severe hypoxemia

    SpO₂ <80% during intubation

    Measured: 30 minutes

Secondary outcomes (2)
  1. Major peri-intubation complications

    Severe hypotension

    Measured: 30 minutes

  2. hospital mortality

    rate of mortality

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start23 Apr 2026
  3. Primary completion30 May 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07297420
Sponsor's protocol ID
AYTEN-1
Status last verified
Oct 2026
First submitted
24 Nov 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Airway Complication of Anesthesia, run by Zeliha Alicikus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe hypoxemia (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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