- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07654153
Surgical Positions and Postoperative Atelectasis: A Lung Ultrasound Study
Evaluation of the Effect of Surgical Positions Under General Anesthesia on Postoperative Atelectasis Using Lung Ultrasonography
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Study Groups: Patients will be divided into 4 groups according to the surgical position to be given during the operation:
- Group 1 (Supine, n=25)
- Group 2 (Prone, n=25)
- Group 3 (Lateral Decubitus, n=25)
- Group 4 (Lithotomy, n=25) All patients will receive standard anesthesia induction and maintenance with 1 mcg/kg fentanyl citrate, 2 mg/kg propofol, 0.6 mg/kg rocuronium intravenously, followed by maintenance with desfluran at a MAC of 0.8-1.2 (if necessary). Patient demographic data (age, gender, height, weight, BMI, ASA score, comorbidities) and intraoperative data (heart rate, SpO2, mean arterial pressure, duration of surgery, surgical position, applied PEEP level) will be recorded.
Lung Ultrasonography (LUS) Protocol: LUS evaluation, Dr. The ultrasound will be performed by Burak Ağar using a Mindray ultrasound device [Device brand/model and probe type, e.g., 3.5-5 MHz convex or 7-12 MHz linear probe]. LUS will be performed using a 12-zone protocol consisting of 6 standard zones (upper and lower quadrants of the anterior, lateral, and posterior regions) for both hemithoraxes. The evaluation will be performed at 3 different time points:
- Preoperative (T0): Immediately before anesthesia induction, in the supine position (Baseline).
- Postoperative (T1): Immediately before the patient is awakened, in the supine position.
Postoperative (T2): 20 minutes after the patient is transferred to the PACU. MLUS Scoring: Each region will be scored between 0-3 according to lung ventilation (MLUS Score):
- 0 Points: Normal ventilation (presence of A-line, fewer than 3 B-lines)
- 1 Point: Minor ventilation loss (≥ 3 B-lines or subpleural consolidations ≤ 1 cm in diameter separated by a normal pleural line)
- 2 Points: Moderate ventilation loss (Multiple small subpleural consolidations ≤ 1 cm in diameter separated by multiple and converging B-lines or a thickened/irregular pleural line)
- 3 Points: Severe ventilation loss (At least one consolidation > 1 cm in diameter or subpleural consolidations > 1x2 cm in diameter) The total MLUS score will be obtained by summing the scores of the 12 regions (Minimum 0, Maximum 36). Atelectasis will be defined as "predisposition to atelectasis when each quadrant score is 2 or 3".
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Sivas
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Sivas, Sivas, Turquie (Türkiye), 58140
- Sivas Cumhuriyet University
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Contact:
- oğuz gündoğdu
- Numéro de téléphone: +905545945469
- E-mail: droguzgundogdu@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Being between 18-80 years of age
- Having ASA I-III status
- Planning elective surgery under general anesthesia
- Agreeing to participate in the study and signing the consent form
Exclusion Criteria:
- Patients requiring emergency surgery
- Patients with ASA IV or higher
- Presence of a known serious preoperative lung disease (COPD, Asthma, Pneumonia, Pleural effusion, Pneumothorax, Interstitial lung disease, Bronchiectasis, etc.)
- History of neuromuscular disease
- Body Mass Index (BMI) > 35 kg/m² (Morbid obesity)
- Presence of chest wall deformity or skin lesions that would obstruct LUS imaging
- Cases with an operative duration of less than 60 minutes or more than 300 minutes
- Patients with a history of thoracotomy, sternotomy, or prior open thoracic surgery
- Patients with alcohol or drug dependence
- Patients with significant anemia
- Patients who are pregnant or lactating
- Patients who develop laryngospasm following extubation
- Refusal to provide consent or inability to cooperate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Group 1
Supine position
|
Lung Ultrasound (LUS) Protocol: The LUS evaluation will be performed by Dr. Burak Ağar using a Mindray ultrasound device [Device brand/model and probe type, e.g., 3.5-5 MHz convex or 7-12 MHz linear probe]
|
|
group 2
prone position
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Lung Ultrasound (LUS) Protocol: The LUS evaluation will be performed by Dr. Burak Ağar using a Mindray ultrasound device [Device brand/model and probe type, e.g., 3.5-5 MHz convex or 7-12 MHz linear probe]
|
|
group 3
lateral decubitus
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Lung Ultrasound (LUS) Protocol: The LUS evaluation will be performed by Dr. Burak Ağar using a Mindray ultrasound device [Device brand/model and probe type, e.g., 3.5-5 MHz convex or 7-12 MHz linear probe]
|
|
Group 4
lithotomy
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Lung Ultrasound (LUS) Protocol: The LUS evaluation will be performed by Dr. Burak Ağar using a Mindray ultrasound device [Device brand/model and probe type, e.g., 3.5-5 MHz convex or 7-12 MHz linear probe]
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Modified Lung Ultrasound Score
Délai: 1. (T0):Immediately before anesthesia induction, in the supine position 2.(T1): Immediately before the patient is awakened, in the supine posit 3.(T2):Twenty minutes after the patient was admitted to the PACU (Post-Anesthesia Care Unit)
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MLUS Scoring: Each region will be scored between 0-3 according to lung ventilation (MLUS Score):
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1. (T0):Immediately before anesthesia induction, in the supine position 2.(T1): Immediately before the patient is awakened, in the supine posit 3.(T2):Twenty minutes after the patient was admitted to the PACU (Post-Anesthesia Care Unit)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-11/01
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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