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Heated Humidified Oxygen in PACU Patients

NCT07778420 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-09-01

No results posted yet for this study

Summary

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.

Conditions

  • Hypoxemia
  • Postoperative Complications
  • Anesthesia Recovery Period

Interventions

DEVICE

Heated and Humidified Oxygen Therapy

Oxygen 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.

DEVICE

Room-Temperature Oxygen Therapy

Room-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.

Sponsors & Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Lei Ma, MD PhD · Second Affiliated Hospital of Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778420 on ClinicalTrials.gov