Transoral Oxygen Delivery for Mouth-Breathing Patients After Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, crossover trial enrolling 64 adults who persistently mouth-breathe after elective thoracic or abdominal surgery. Each participant receives both standard nasal cannula oxygen at 4 L/min for 10 minutes and transoral nasal cannula oxygen at 4 L/min for 10 minutes in random order, with a washout period between interventions. The primary aim is to compare the immediate oxygenation effects of the two delivery methods in the PACU. Eligibility includes adults 18 or older with ASA I–III, undergoing elective surgery under general anesthesia and recovered spontaneous breathing with confirmed mouth breathing by a standardized assessment. Exclusions include severe obstructive sleep apnea, or severe hypoxemia requiring escalation of therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged older than 18 years;
2. American Society of Anesthesiologists (ASA) physical status classification I-III;
3. Undergoing elective thoracic or abdominal surgery under general anesthesia with postoperative transfer to the postanesthesia care unit (PACU);
4. Anticipated PACU stay of at least 30 minutes to allow an adequate observation window for data collection;
5. Recovery of spontaneous breathing after tracheal extubation, and confirmed as persistent mouth breathing by the standardized three-step assessment procedure (visual screening, cotton-fiber airflow verification, and mirror confirmation);
6. Written informed consent signed by the patient or a family member.

Exclusion Criteria:

1. Preoperative diagnosis of severe obstructive sleep apnea-hypopnea syndrome (apnea-hypopnea index \[AHI\] \>30) or requirement for continuous positive airway pressure therapy;
2. Severe hypoxemia requiring immediate escalation of oxygen therapy (SpO2 \<90% or PaO2 \<60 mmHg);
3. Requirement for reintubation or placement of an oropharyngeal or nasopharyngeal airway after surgery;
4. Hemodynamic instability requiring vasoactive agents to maintain mean arterial pressure (MAP \<65 mmHg).

Where it's running

• Nanjing First Hospital, Nanjing Medical University
  Nanjing, Jaingsu, China Recruiting

Study contacts

• Principal investigator: Shuai Wang — Nanjing First Hospital, Nanjing Medical University
• Study coordinator: Shuai Wang
• Email: wangshuaisj@126.com
• Phone: +8618852095101

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.