Respiratory
Conditions
Interventions
Sponsors
faculty of applied health sciences technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults = 18 years. • BMI = 30 kg/m². Patients will be stratified into World Health Organization (WHO) obesity classes for subgroup analysis: Class I (Obese): BMI 30.0 – 34.9 kg/m² Class II (Severely Obese): BMI 35.0 – 39.9 kg/m² Class III (Morbidly Obese): BMI = 40.0 kg/m² BMI subgroup analyses are exploratory and hypothesis-generating. • ICU patients requiring orotracheal intubation. • Patient clinically stable enough to allow a brief (30–60 second) ultrasound examination without delaying airway intervention (SpO2 = 90% on pre-oxygenation, SBP = 90 mmHg, no active seizures). This study evaluates airway ultrasound in patients stable enough to permit brief pre-intubation assessment; findings may not generalize to crash intubations or extreme physiological instability.
Exclusion criteria
Exclusion criteria: • Severe hypoxemia (SpO2 < 90% despite maximal pre-oxygenation (e.g., with non-rebreather mask at 15 L/min, or non-invasive ventilation, or bag-valve-mask with PEEP, as determined by the treating clinician) and requiring immediate intubation), hemodynamic instability, or imminent airway compromise requiring immediate intubation. • Maxillofacial or neck trauma, neck masses, or distorted anatomy preventing adequate scanning. • Inability to expose the anterior neck (e.g., dressings, cervical collars). • Patients intubated before ultrasound could be safely performed. • Patients for whom the treating intensivist elects to bypass the protocol for clinical safety. • Patients with a previously documented history of failed intubation or surgical airway will be excluded from the primary analysis to minimize confounding by this extreme risk factor. However, these patients, if encountered, will be enrolled in a separate exploratory subgroup to evaluate the performance of ultrasound in this specific high-risk population.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difficult laryngoscopy defined as a Cormack-Lehane (C-L) grade 3 or 4 visualized during the first attempt at direct laryngoscopy (or grade =2b at videolaryngoscopy, mapped to C-L 3/4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 intubation attempts ;Requirement of an alternative device or technique (e.g., video laryngoscopy, bougie, stylet) ;Need for assistance from a second operator (excluding cricoid pressure) ;Operator-reported “difficult intubation” (Yes/No) ;Number of intubation attempts ;Use of airway adjuncts (bougie, stylet, alternative blade) ;Significant oxygen desaturation (SpO2 20% decrease in SBP from baseline, or need for fluid bolus/new/increased vasopressor) ;Major complications (esophageal intubation, aspiration, dental/oropharyngeal trauma with bleeding, cardiac arrest) ;Time to successful intubation (seconds from first laryngoscope insertion to first EtCO2 waveform) ;First-pass success (successful tube placement with only one attempt, no alternative devices/operators) ;Scan completion time (seconds from transducer placement to acquisition of final saved image) ;Proportion of patients in whom ultrasound could be safely completed, mean/median scan duration, reasons for non-feasibility | — |
Countries
Egypt
Contacts
Public Contactkhaled gaballah
assistant professor of anesthesia and intensive care
Outcome results
None listed