- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07752173
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours
Comparison of Acute Airway/Respiratory Complications and Intervention Requirements in Extubations Performed During On-Hours Versus Off-Hours: A Prospective Observational Cohort Study
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Mehmet Yilmaz, Md
- Telefonnummer: 05052174432
- E-Mail: drmyilmaz33@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Ali Mete Temel, Md
- Telefonnummer: +905438465215
- E-Mail: metetemel60@hotmail.com
Studienorte
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Izmıt
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Kocaeli, Izmıt, Türkei (türkiye), 41001
- Rekrutierung
- Kocaeli City Hospital
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Kontakt:
- Mehmet Yilmaz, Md
- Telefonnummer: 05052174432
- E-Mail: drmyilmaz33@gmail.com
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Unterermittler:
- Mehmet Yilmaz, Md
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Kontakt:
- Ali Mete Temel, Md
- Telefonnummer: +905438465215
- E-Mail: metetemel60@hotmail.com
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Hauptermittler:
- Ali Mete Temel, Md
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Age ≥ 18 years
Undergoing elective or emergency surgery under general anaesthesia with endotracheal intubation
Planned tracheal extubation in the operating theatre or post-anaesthesia care unit (PACU)
Provision of written informed consent (or deferred consent for emergency cases, in accordance with national regulations)
Exclusion Criteria:
- Patients undergoing surgery under regional anaesthesia or sedation without endotracheal intubation
Patients with a tracheostomy in situ
Patients who remain intubated and are transferred to the intensive care unit (ICU) postoperatively
Patients undergoing cardiothoracic surgery involving cardiopulmonary bypass
Emergency airway management performed outside the operating theatre (e.g., ICU, emergency department)
Patients with known or suspected difficult airway requiring awake fibreoptic intubation
Patients who refuse to provide informed consent or withdraw consent during the study
Pregnant patients
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
On-Hours
On-hours group: Extubations performed between 08:00 and 16:00 on weekdays (Monday to Friday), excluding public holidays.
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An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.
Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure.
This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation.
The KSS score will be recorded as a predictor/exposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation.
This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).
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Off-Hours
Off-hours group: Extubations performed after 16:00 on weekdays, as well as all extubations performed on weekends and public holidays, regardless of the time of day
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An extubation attempt is the planned, deliberate removal of the endotracheal tube from the patient's trachea, beginning with preparatory manoeuvres (such as oropharyngeal suctioning and cuff deflation) and ending with the complete withdrawal of the tube and establishment of a patent native airway with adequate spontaneous breathing.
Description: The Karolinska Sleepiness Scale (KSS), a validated 9-point Likert scale (1 = extremely alert, 9 = very sleepy, fighting sleep), will be administered to the attending anaesthetist responsible for performing the extubation immediately prior to the extubation procedure.
This assessment is performed to objectively quantify the clinician's subjective level of sleepiness and fatigue at the time of extubation.
The KSS score will be recorded as a predictor/exposure variable to evaluate the association between anaesthetist fatigue and the occurrence of acute airway and respiratory complications during extubation.
This assessment is applied uniformly across both study groups (on-hours and off-hours extubations).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of Desaturation During Extubation
Zeitfenster: 30 min. after extubation
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Description: The occurrence of desaturation during the extubation procedure itself, defined as a peripheral oxygen saturation (SpO₂) < 90% lasting for ≥ 30 seconds (or a ≥ 5% decrease from baseline in patients with pre-existing hypoxaemia), measured from the initiation of extubation manoeuvres (cuff deflation and suctioning) until the complete withdrawal of the endotracheal tube. Time Frame: Desaturation occurring during the extubation attempt and within the first 30 minutes post-extubation. |
30 min. after extubation
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Other acute airway/respiratory complications
Zeitfenster: 30 min. after extubation
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(laryngospasm, airway obstruction, bronchospasm, aspiration, apnoea, haemodynamic instability, arrhythmias, unplanned reintubation, surgical airway).
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30 min. after extubation
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Intervention requirement by type
Zeitfenster: 30 min. after extubation
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(simple airway manoeuvres, bag-mask ventilation, pharmacological agents, reintubation, surgical airway)
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30 min. after extubation
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Mehmet Yilmaz, Kocaeli City Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Xie Q, Shen Z, Pan M, Li Y, Luo Z, Wang C, Zhao L, Fang Y, Ding X, Teng J, Xu J. Weekend effect on the incidence and outcomes of cardiac surgery associated - acute kidney injury. BMC Cardiovasc Disord. 2023 Oct 27;23(1):524. doi: 10.1186/s12872-023-03431-4.
- Patel MS, Thomas JJ, Aguayo X, Gutmann D, Sarwary SH, Wain M. The Effect of Weekend Surgery on Outcomes of Emergency Laparotomy: Experience at a High Volume District General Hospital. Cureus. 2022 Mar 27;14(3):e23537. doi: 10.7759/cureus.23537. eCollection 2022 Mar.
- Ash-Rafzadeh H, Chambers TJ, Velez FO, Moodie CC, Garrett JR, Fontaine JP, Toloza EM. Effect of Surgical Day of Week on Postoperative Outcomes After Robotic-Assisted Pulmonary Lobectomy. Cureus. 2023 Feb 23;15(2):e35379. doi: 10.7759/cureus.35379. eCollection 2023 Feb.
- Maman D, Steinfeld Y, Berkovich Y. No Weekend Effect in Elective Primary Total Knee Arthroplasty: A Nationwide Analysis of 437,121 U.S. Cases. J Clin Med. 2025 Dec 12;14(24):8816. doi: 10.3390/jcm14248816.
- Cortegiani A, Gregoretti C, Neto AS, Hemmes SNT, Ball L, Canet J, Hiesmayr M, Hollmann MW, Mills GH, Melo MFV, Putensen C, Schmid W, Severgnini P, Wrigge H, Gama de Abreu M, Schultz MJ, Pelosi P; LAS VEGAS Investigators, the PROVE Network, and the Clinical Trial Network of the European Society of Anaesthesiology. Association between night-time surgery and occurrence of intraoperative adverse events and postoperative pulmonary complications. Br J Anaesth. 2019 Mar;122(3):361-369. doi: 10.1016/j.bja.2018.10.063. Epub 2019 Feb 8.
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
Zusätzliche relevante MeSH-Bedingungen
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Untersuchungstechniken
- Epidemiologische Methoden
- Therapeutika
- Datenerfassung
- Gesundheitsbewertungsmechanismen
- Qualität der Gesundheitsversorgung
- Öffentliche Gesundheit
- Umwelt und öffentliche Gesundheit
- Atemwegsmanagement
- Umfragen und Fragebögen
- Atemwegsertubation
Andere Studien-ID-Nummern
- KSH-2026-89
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