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.
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
- Conditions the study is for
- Obesity, Airway Complication of Anesthesia, Intubation; Difficult or Failed
- 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
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 group | Role | What they receive |
|---|---|---|
| Group 1 | Morbidly obese (BMI 40-49.9 kg/m²) Receives: Procedure: endotracheal intubation | |
| Group 2 | Super 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.
Severe hypoxemia
SpO₂ <80% during intubation
Measured: 30 minutes
Secondary outcomes (2)
Major peri-intubation complications
Severe hypotension
Measured: 30 minutes
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.
- First posted22 Dec 2025
- Study start23 Apr 2026
- Primary completion30 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zeliha Alicikus
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Zeliha Alicikus, Umraniye Education and Research Hospital
- Investigators
- Ayten SARAÇOĞLU, Prof,MD, Study director, Florida University Jacksonville
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Intubation Adverse Airway Events in Critically Ill Patients With Morbid and Super Obesity: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07297420
- Acronym / sponsor ID
- AYTEN-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Zeliha AlicikusOther government
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: endotracheal intubationMorbidly obese (BMI 40-49.9 kg/m²) |
| Group 2 | – | Procedure: endotracheal intubationSuper obese (BMI ≥50 kg/m²) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- BMI ≥40
- Admission to the surgical ICU and intubated during ICU stay
- Availability of complete clinical data
Key exclusion criteria (4 listed)
- Age < 18 years
- BMI<40
- No intubation
- Incomplete or missing medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endotracheal intubationadult trauma patients (≥18 years) admitted to the Surgical Intensive Care Unit | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Severe hypoxemia
Time frame: 30 minutes
SpO₂ <80% during intubation
2 secondary outcomes
Major peri-intubation complications
Time frame: 30 minutes
hospital mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayten SARAÇOĞLU, Prof,MD study director
Florida University Jacksonville
1 site in 1 country: see every site and its status.
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.