- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Selvinaz Yüksel Tanrıverdi, MD
- Telefonní číslo: +0902242955000
- E-mail: yukselselvinaz@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Total Lung Ultrasonography Score (LUS Score)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Significant Atelectasis
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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