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High-flow oxygen and sedation to support difficult intubation in patients with maxillofacial abscess

Study on high-flow oxygenation and conscious sedation for difficult tracheal intubation via a flexible endoscope in patients undergoing maxillofacial abscess surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250929010
Enrollment
100
Registered
2025-09-29
Start date
2023-11-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with maxillofacial abscess complicated by trismus indicated for surgery under general anesthesia High-flow oxygenation Conscious sedation Target-controlled infusion of propofol Maxillofacial abscess Trismus Flexible endoscope Fiberoptic intubation

Interventions

Preoxygenation with HFNO at 30 L/min FiO2 1.0. After 5 minutes of preoxygenation, sedation was induced with TCI-propofol using the Schnider pharmacokinetic-pharmacodynamic model. The initial target ef
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
High flow nasal oxygen (HFNO), conscious sedation with target-controlled infusion (TCI) of propofol and topical anesthesia of the upper airway for difficult tracheal intubation via a flexible endosco

Sponsors

Vietnam Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. ASA physical status I, II, or III 3. Provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients requiring emergency airway management with insufficient time to perform tracheal intubation according to the study protocol 2. Severe cervical anatomical deformities preventing identification of the cricothyroid membrane as per the study protocol 3. Patients receiving anticoagulant therapy or with uncontrolled coagulopathy 4. Presence of cardiac arrhythmia or hypertension requiring treatment but not adequately controlled 5. Patients whose preoperative fasting interval for eating and drinking before surgery did not meet the required duration of at least 6 hours for solid food and at least 2 hours for clear fluids from the last eating and drinking intake 6. Pregnant women 7. Patients with neuropsychiatric disorders associated with impaired consciousness Withdrawal criteria: 1. Anaphylaxis or contraindications to study medications 2. Upper airway obstruction and/or tracheal stenosis with insufficient lumen to allow passage of the endotracheal tube 3. Patients who are uncooperative or unable to maintain the required position according to the study protocol 4. Patients in whom the study procedures are not performed fully and correctly as per protocol 5. Incomplete medical records

Design outcomes

Primary

MeasureTime frame
Time to tracheal intubation Immediately after successful tracheal intubation second,Ease of tracheal intubation Immediately after successful tracheal intubation Ease of tracheal intubation according to Sethi,SpO2 During and immediately after tracheal intubation percent,PaO2 1 minute before and immediately after intubation mmHg,Time to glottic exposure Time to glottic exposure was defined as the time from insertion of the flexible endoscope into the nasal cavity to the point at which the glottis was reached and fully visualized Second,Adverse events Adverse events occurring before, during, and immediately after tracheal intubation were recorded. Adverse events occurring before, during, and immediately after tracheal intubation were recorded.

Secondary

MeasureTime frame
Pain level During and immediately after tracheal intubation Pain level according to the Analgesia/Nociception Index (ANI)

Countries

Vietnam

Contacts

Public ContactLuan Nguyen

Vietnam Military Medical University

doctorvanluanqy@gmail.com0865312689

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026