- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07676760
HFNC for Postoperative Atelectasis After Laparoscopic Surgery
The Role of High-Flow Nasal Cannula in Monitoring Postoperative Atelectasis With Lung Ultrasonography After Laparoscopic Surgery: A Prospective Observational Study
Study Overview
Status
Intervention / Treatment
Detailed Description
General anesthesia with laparoscopic surgery causes cephalad diaphragm displacement and reduction in functional residual capacity due to pneumoperitoneum and Trendelenburg positioning, predisposing patients to atelectasis development. Perioperative atelectasis has been reported in up to 90% of patients under general anesthesia, increasing the risk of hypoxemia, prolonged oxygen therapy, and postoperative pulmonary complications (PPCs).
High-flow nasal cannula (HFNC) oxygen therapy supports alveolar recruitment, enhances mucociliary clearance, and may reduce post-extubation atelectasis through heated and humidified gas delivery and generation of low-level positive end-expiratory pressure (PEEP). Randomized controlled trials have demonstrated that HFNC significantly reduces the incidence and severity of atelectasis assessed by LUS in robot-assisted laparoscopic rectal cancer surgery. Lung ultrasonography (LUS) has emerged as a reliable, rapid, and radiation-free method for diagnosis and monitoring of perioperative atelectasis with 87.7% sensitivity and 92.1% specificity.
This study is designed as a prospective, observational, single-center, parallel-group cohort study. No intervention or randomization will be performed. HFNC application will be left entirely to the clinician's discretion; the investigator will not be involved in the treatment process.
Patients in whom HFNC is initiated by the clinician in the post-extubation period will be defined as Group 1 (HFNC group), and patients receiving conventional oxygen therapy will be defined as Group 2 (Control group). HFNC application will be considered valid if initiated within 30 minutes of extubation.
LUS assessments will be performed by an independent investigator blinded to group assignment at four time points: T0 (preoperative), T1 (post-extubation), T2 (30th minute in the recovery unit), and T3 (discharge from the recovery unit). An additional LUS assessment is planned at postoperative 24 hours (T4). The Monastesse modified LUS score will be used at each assessment, evaluating 12 thoracic regions (6 segments per hemithorax along parasternal, anterior axillary, and posterior axillary lines), with a total LUS score ranging from 0 to 36 points.
HFNC parameters (flow rate, FiO₂, duration) and intraoperative variables (type and duration of surgery, anesthesia duration, insufflation duration, pneumoperitoneum pressure, Trendelenburg angle, total fluid intake, urine output) as well as postoperative variables (minimum SpO₂ in the recovery unit, length of hospital stay) will be considered as potential confounding factors in the statistical analysis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Selvinaz Yüksel Tanrıverdi, MD
- Phone Number: +0902242955000
- Email: yukselselvinaz@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18 years and older
- Patients scheduled for elective laparoscopic surgery (general surgery, urology, gynecology)
- Patients undergoing mechanical ventilation under general anesthesia
- ASA physical status I-III
- Patients providing written informed consent
Exclusion Criteria:
- Severe or uncontrolled chronic obstructive pulmonary disease, asthma, or other chronic pulmonary diseases
- Patients with atelectasis or pleural effusion detected on preoperative lung ultrasonography
- Patients requiring intraoperative recruitment maneuver
- ASA physical status IV or above
- Patients receiving spinal or epidural anesthesia
- Cases requiring conversion to laparoscopy or laparotomy
- Patients refusing to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HFNC Group
Patients in whom high-flow nasal cannula (HFNC) oxygen therapy is initiated by the clinician within 30 minutes of extubation after elective laparoscopic surgery.
|
HFNC Group
|
|
Control Group
Patients receiving conventional oxygen therapy after extubation following elective laparoscopic surgery.
|
Standard oxygen therapy administered via face mask or nasal cannula after extubation following elective laparoscopic surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Lung Ultrasonography Score (LUS Score)
Time Frame: T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
Total lung ultrasonography score assessed using the Monastesse modified LUS scoring system.
Each hemithorax is divided into 6 segments along parasternal, anterior axillary, and posterior axillary lines, evaluating a total of 12 thoracic regions with a total score ranging from 0 to 36 points.
Scores are compared between HFNC and conventional oxygen therapy groups.
|
T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Significant Atelectasis
Time Frame: T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
Proportion of patients with at least one lung region scoring ≥2 on the LUS scoring system (coalescing B-lines/irregular pleura or consolidation >1×2cm) at each time point.
|
T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit
|
|
Minimum SpO₂ in the Post-Anesthesia Care Unit (PACU)
Time Frame: From extubation to PACU discharge, up to 2 hours
|
Minimum oxygen saturation recorded during the entire post-anesthesia care unit stay.
|
From extubation to PACU discharge, up to 2 hours
|
|
Incidence of Hypoxemia
Time Frame: From extubation to PACU discharge, up to 2 hours
|
Proportion of patients with SpO₂ below 95% during the post-anesthesia care unit stay.
|
From extubation to PACU discharge, up to 2 hours
|
|
Incidence of Severe Hypoxemia
Time Frame: From extubation to PACU discharge, up to 2 hours
|
Proportion of patients with SpO₂ below 90% during the post-anesthesia care unit stay.
|
From extubation to PACU discharge, up to 2 hours
|
|
Postoperative Complications
Time Frame: From surgery to hospital discharge, up to 7 days
|
Incidence and type of postoperative complications recorded during hospital stay.
|
From surgery to hospital discharge, up to 7 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Han L, Ren D, Zhu M, Pan L, Zhu Y. High-flow nasal cannula oxygen therapy in post-anesthesia care unit (PACU) reduces postextubation atelectasis in patients undergoing esophageal cancer surgery: A randomized controlled trial. PLoS One. 2026 May 5;21(5):e0348511. doi: 10.1371/journal.pone.0348511. eCollection 2026.
- Sun L, Wang J, Wei P, Ruan WQ, Guo J, Yin ZY, Li X, Song JG. Randomized Controlled Trial Investigating the Impact of High-Flow Nasal Cannula Oxygen Therapy on Patients Undergoing Robotic-Assisted Laparoscopic Rectal Cancer Surgery, with a Post-Extubation Atelectasis as a Complication. J Multidiscip Healthc. 2024 Jan 26;17:379-389. doi: 10.2147/JMDH.S449839. eCollection 2024.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BursaYIERHTanriverdi-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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