Heated Humidified Oxygen in PACU Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University

About this trial

This study aims to determine whether heated and humidified oxygen therapy, compared with conventional room-temperature oxygen therapy, reduces the incidence of early hypoxemia in adult patients recovering from general anesthesia in the Post-Anesthesia Care Unit (PACU).

Hypoxemia is a common and potentially life-threatening complication during PACU recovery, resulting from residual anesthetics, decreased upper airway muscle tone, atelectasis, and suppression of hypoxic pulmonary vasoconstriction (HPV). Heated and humidified oxygen may offer benefits by preserving optimal HPV function, protecting airway mucosa, and reducing respiratory resistance.

This is a prospective, multicenter, randomized, superiority trial with a parallel-group design. A total of 2,000 adult patients (ASA class I-III) undergoing general anesthesia will be enrolled and randomly assigned in a 1:1 ratio to receive either heated and humidified oxygen (37°C, 5 L/min via face mask) or room-temperature oxygen (room temperature, 5 L/min via face mask).

The primary outcome is the incidence of hypoxemia, defined as SpO₂ ≤ 90% lasting ≥ 5 seconds, within 10 minutes after initiation of the intervention. Secondary outcomes include severe hypoxemia (SpO₂ ≤ 85%), requirement for airway interventions, lowest SpO₂ value, PACU length of stay, postoperative shivering, and agitation. Safety outcomes include nasal discomfort, epistaxis, and device-related adverse events.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Undergoing elective or emergency surgery under general anesthesia with endotracheal intubation

Ramsay Sedation Score of 2-4 at 1 minute after extubation

ASA physical status class I-III

Disqualifiers

Pre-existing hypoxemia (SpO₂ < 90% on room air)

Pre-existing diagnosis of severe chronic obstructive pulmonary disease (GOLD grade 3-4), interstitial lung disease, or uncontrolled asthma

Severe cardiovascular disease (NYHA class III-IV heart failure, unstable angina)

Neuromuscular disease affecting respiratory function

Trial design

Treatments tested in this trial

  • Heated and Humidified Oxygen Therapy
  • Room-Temperature Oxygen Therapy

Treatment groups

2,000 Participants
are divided into 2 treatment groups