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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Heated and Humidified Oxygen Therapy
DeviceOxygen heated to 36-37°C using a dry-heat blood/fluid warmer with a flexible heating sleeve, delivered at 5 L/min via face mask. Temperature measured every 5 minutes.
Room-Temperature Oxygen Therapy
DeviceRoom-temperature oxygen delivered at 5 L/min via face mask through a bubble humidifier. Same heating device but switched off (sham), with simulated temperature measurements recorded as room temperature.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Heated and Humidified Oxygen GroupExperimental treatment 1 intervention
Group B: Room-Temperature Oxygen GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Hypoxemia Within 10 Minutes
Hypoxemia is defined as SpO₂ ≤ 90% lasting for ≥ 5 seconds during the 10-minute period immediately after initiation of the study intervention. Only events occurring during normal waveform quality are counted.
Time frame
Within 10 minutes after intervention initiationSecondary outcomes
1
Incidence of Severe Hypoxemia
Severe hypoxemia is defined as SpO₂ ≤ 85% lasting for ≥ 5 seconds within 10 minutes of intervention initiation.
Time frame
Within 10 minutes after intervention initiation2
Lowest SpO₂ Value
The lowest SpO₂ value recorded during the 10-minute period after intervention initiation, based on continuous monitoring.
Time frame
Within 10 minutes after intervention initiation3
Significant SpO₂ Drop >4% From Baseline
Proportion of patients with a decline in SpO₂ of more than 4% from baseline within 10 minutes of intervention initiation.
Time frame
Within 10 minutes after intervention initiation4
Need for Airway Interventions
Proportion of patients requiring jaw thrust, increase in oxygen flow rate (\>5 L/min), or bag-mask ventilation during the entire PACU stay.
Time frame
From enrollment to PACU discharge, up to 6 hoursSponsors and contacts
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Source ClinicalTrials.gov
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