NCT07060625

Brief Summary

Thoracoscopic surgery is the most common surgical approach in thoracic surgery, which reduces surgical trauma and postoperative pain compared with open thoracotomy, but postoperative complications should not be overlooked, with hypoxemia being particularly prominent. Postoperative hypoxemia is highly prevalent among patients recovering from non-cardiac surgery, accounting for over one-third of all cases. Hypoxemia impairs wound healing and leads to other severe complications such as cerebral dysfunction, arrhythmia, and myocardial ischemia, all of which adversely affect postoperative recovery. Although oxygen therapy can prevent and treat hypoxemia, many patients still experience hypoxia in the post-anesthesia care unit (PACU). Numerous studies have investigated various ventilation techniques aimed at enhancing postoperative pulmonary function, but the benefits of protective ventilation strategies may be lost during emergence from anesthesia. Several other studies also indicate that intraoperative ventilation measures do not improve postoperative pulmonary function. The lack of evidence demonstrating the efficacy of oxygen therapy or protective ventilation techniques in treating postoperative hypoxemia underscores the need to explore alternative strategies. Patient positioning during emergence from anesthesia is associated with perioperative and postoperative complications. Although no consensus exists on the optimal patient position during emergence, the supine position is often favored by anesthesiologists due to its simplicity and ease of monitoring. However, the reduced functional residual capacity associated with the supine position tends to promote airway closure and diminish gas exchange.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Dec 2024Sep 2026

Study Start

First participant enrolled

December 23, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

July 11, 2025

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

June 23, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-PACU hypoxemia

    defined as SpO2 \<90% for less than 60 seconds

    Perioperative

Secondary Outcomes (9)

  • The incidence of severe hypoxemia

    Perioperative

  • the time of the first episode of hypoxemia

    Perioperative

  • Airway first aid

    Perioperative

  • Breathing comfort

    Perioperative

  • Wound pain VAS score

    measured and recorded at rest and cough, 5 and 30 minutes after extubation, before leaving PACU and 24,48 and 72 hours postoperative

  • +4 more secondary outcomes

Other Outcomes (4)

  • Adverse events related to position

    Perioperative

  • 15-item recovery quality scale (Quality of Recovery-15, QoR-15) scores

    at 1 and 3 days postoperative

  • Postoperative inflammatory markers

    On the first day after surgery

  • +1 more other outcomes

Study Arms (2)

Exposure group

Semi-recumbent position during anesthesia recovery

Behavioral: Semi-reclining position

Non exposed group

Supine position during anesthesia recovery

Interventions

During anesthesia recovery, the patient's position should be in a semi-recumbent position

Exposure group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing thoracoscopic lobectomy and segmental resection

You may qualify if:

  • Age 18-85 years old; Undergo thoracoscopic segment/lobectomy; American Society of Anesthesiologists (ASA) grade 1\~3

You may not qualify if:

  • Patients with mental or cognitive dysfunction who cannot communicate normally; Patients with tracheal catheters retained in ICU; Patients with cervical spondylosis, ankylosing spondylitis and other patients who cannot lift their upper body; Patients who have participated in other clinical trials; Patients who refuse to sign informed consent; Patients who have had chest surgery in the past.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200090, China

Location

MeSH Terms

Conditions

Lung NeoplasmsDiseaseHypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Yang Hao, postdoctor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
308 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post-doctoral

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 11, 2025

Study Start

December 23, 2024

Primary Completion

December 22, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

July 11, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations