- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Selvinaz Yüksel Tanrıverdi, MD
- Telefonnummer: +0902242955000
- E-mail: yukselselvinaz@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Lung Ultrasonography Score (LUS Score)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Significant Atelectasis
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BursaYIERHTanriverdi-002
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