- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07575776
Effect of High-Flow Nasal Oxygen on Laryngoscopic View
Effect of Different Flows Using High-Flow Nasal Oxygen (HFNO) on Laryngoscopic View Quality During Videolaryngoscopy
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Anaesthetic management Anaesthesia induction and airway management will be standardized as far as clinically feasible. Standard monitoring will be applied according to institutional practice. Preoxygenation will be performed using high-flow nasal oxygen (HFNO). General anaesthesia will be induced using standard intravenous agents, followed by administration of neuromuscular blockade to facilitate laryngoscopy. Mask ventilation will be performed as clinically indicated.
Videolaryngoscopy will be performed using a standardized device and blade type whenever possible. All procedures will be performed by anesthesiologists experienced in videolaryngoscopy.
Study procedure
After induction of anaesthesia and achievement of adequate conditions for laryngoscopy, videolaryngoscopy will be performed. During a single laryngoscopic sequence, images of the laryngeal view will be obtained under three predefined HFNO flow conditions:
- 0 L/min
- 40 L/min
- 60 L/min At each flow level, once a stable laryngeal view will be achieved, a still image will be captured using the videolaryngoscope recording system. The laryngoscope position will be maintained as stable as possible during acquisition of all three images. No attempt at tracheal intubation will be made during image acquisition.
After completion of the image capture protocol, tracheal intubation will be performed according to standard clinical practice.
All images will be anonymized and stored for subsequent offline analysis. Image assessment Captured images will be evaluated offline by an independent anesthesiologist blinded to HFNO flow rates and patient identity. Where applicable, evaluation will be performed by more than one assessor to allow assessment of inter-rater agreement.
Each image will be assessed using predefined objective and subjective measures (Percentage of Glottic Opening, Likert scale).
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Age ≥18 years
- Scheduled for endotracheal intubation under general anesthesia
- Use of videolaryngoscopy
Exclusion Criteria:
- Anticipated difficult airway
- Emergency intubation
- Contraindications to HFNO
- Inability to obtain adequate video recording
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Group HFNO
Adult patients with HFNO support for airway management
|
Different flows will be applied to patients undergoing general anaesthesia during airway management.
In this arm flow will be 0 l/min.
During these flows images will be captured using videolaryngoscope.
Different flows will be applied to patients undergoing general anaesthesia during airway management.
In this arm flow will 40 l/min.
During these flows images will be captured using videolaryngoscope.
Different flows will be applied to patients undergoing general anaesthesia during airway management.
In this arm flow will 60 l/min.
During these flows images will be captured using videolaryngoscope.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Quality of view
Zeitfenster: From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Percentage of glottic opening (POGO score) assessed from recorded videolaryngoscopic images.
|
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cormack-Lehane classification
Zeitfenster: From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Ordinal grading of glottic view using Cormack- Lehane classification.
|
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
|
Subjective image quality (Likert scale)
Zeitfenster: From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Subjective assessment of laryngoscopic image quality rated on a 5-point Likert scale (1 = very poor, 5 = excellent) by independent evaluators blinded to HFNO flow conditions
|
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- HFNORCT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Schwieriger Atemweg
-
Akdeniz University HospitalAbgeschlossenEmergency Airway Management | Gastric Inflation Risk During Bag-Valve-Mask Ventilation | Breathing EmergencyTürkei (türkiye)
-
RWTH Aachen UniversityAbgeschlossenAnästhesie mit LMA (Laryngeal Mask Airway)Deutschland
-
Insel Gruppe AG, University Hospital BernGaslini Children's HospitalAnmeldung auf EinladungAnästhesie | Tracheotomie-Komplikation | Notfall-Front-of-Neck-Airway bei KindernSchweiz
-
University Children's Hospital, ZurichAbgeschlossenNotfall-Front-of-Neck-Airway bei KindernSchweiz
-
Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development... und andere MitarbeiterRekrutierungÖsophagusatresie | Tracheoösophageale Fistel | Trachealstenose | Kehlkopfspalte | Bronchialstenose | Ösophagusbronchus | Congenital High Airway Obstruction SyndromeVereinigte Staaten
Klinische Studien zur HFNO flow 0
-
Yunus EmreNoch keine RekrutierungGallenobstruktion | Gallensteine | Oddis Schließmuskelverengung
-
Ain Shams UniversityNoch keine RekrutierungPrävention intraoperativer HypoxieÄgypten
-
Anita VukovicClinical Hospital Centre Zagreb; General Hospital DubrovnikUnbekanntHypoxie | Ateminsuffizienz | Atemwegsmanagement | Darmspiegelung | Nichtinvasive Beatmung | Tiefe Sedierung
-
University of Split, School of MedicineGeneral Hospital DubrovnikUnbekanntFettleibigkeit | Hypoxie | Ateminsuffizienz | Atemwegsmanagement | Darmspiegelung | Nichtinvasive Beatmung | Tiefe Sedierung
-
University of Split, School of MedicineClinical Hospital Centre ZagrebUnbekanntHypoxie | Ateminsuffizienz | Atemwegsmanagement | Vitrektomie | Nichtinvasive Beatmung | Moderate SedierungKroatien
-
University of PadovaAbgeschlossen
-
Assistance Publique - Hôpitaux de ParisFisher and Paykel Healthcare; Orkyn'Rekrutierung
-
University of Split, School of MedicineClinical Hospital Centre ZagrebUnbekanntApnoe | Fettleibigkeit | Ateminsuffizienz | Sedierungskomplikation | Hypoxische Ateminsuffizienz | Obstruktion der Atemwege, nasalKroatien
-
Shenzhen Second People's HospitalNoch keine Rekrutierung
-
University of PennsylvaniaZurückgezogenPneumonie, viral | COVID | Schweres akutes Atemwegssyndrom Coronavirus 2 | Hypoxämisches AtemversagenVereinigte Staaten