Dynamic Prediction of Sleep Protection Demand on the First Postoperative Night and Its Influence on Ward Process After Thoracoscopic Lobectomy or Segmentectomy
16. juli 2026 oppdatert av: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Dynamic Prediction of First-Night Sleep Protection Needs After Thoracoscopic Lobectomy/Segmentectomy and Analysis of the Impact of Ward Routines
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study to understand postoperative sleep disturbance on the first night after video-assisted thoracoscopic (VATS) lobectomy or segmentectomy.
It mainly wants to answer the question: Can perioperative data collected along the clinical timeline dynamically predict which patients will experience clinically significant sleep disturbance on their first postoperative night?
Participants undergoing elective VATS lung resection will have multidimensional data systematically collected from preoperative screening (including PSQI and GAD-7), intraoperative anesthetic parameters, PACU-to-ward handover, pre-bedtime symptom burden, and follow-up through 1 month.
Three dynamic prediction models (M0 preoperative screening, M1 early postoperative update, and M2 pre-bedtime main model) will be developed using logistic regression with RCSQ-assessed sleep disturbance as the primary outcome, while an explanatory model will quantify the impact of nighttime disruptions such as intravenous infusions, vital sign monitoring, nursing entries, and awakenings.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study combines retrospective data analysis with a single-center prospective non-interventional cohort study.
The primary data collection is prospective, while retrospective data may be used for preliminary analysis or baseline comparison.
Studietype
Observasjonsmessig
Registrering (Antatt)
400
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ruishi Yuan
- Telefonnummer: +86 18726732268
- E-post: police1872@163.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults aged 18 years and older undergoing elective video-assisted thoracoscopic (VATS) lobectomy or segmentectomy within a single-center thoracic surgery perioperative care pathway.
Participants are drawn from the routine inpatient population managed under standard enhanced recovery after surgery (ERAS) protocols, with planned postoperative admission to a general thoracic ward, ASA physical status I-III, capacity to understand and complete study questionnaires, and willingness to provide informed consent.
The population encompasses the perioperative window from preoperative assessment through PACU recovery to the first postoperative night.
Beskrivelse
Inclusion Criteria:
- Aged 18 years or older; Scheduled for elective video-assisted thoracoscopic surgery (VATS) lobectomy or segmentectomy; Planned postoperative admission to a general thoracic surgery ward; American Society of Anesthesiologists (ASA) physical status classification I-III; Capable of understanding questionnaires and verbal communication; Prospective cohort participants who voluntarily enroll in the study and provide written informed consent.
Exclusion Criteria:
- Emergency or trauma-related surgery; Planned direct postoperative admission to the intensive care unit (ICU); Severe cognitive impairment, delirium, or acute phase of psychiatric disorders; Severe hearing, speech or visual impairment precluding completion of assessments; Confirmed pregnancy or breastfeeding status; Chronic long-term use of sedative-hypnotics with unassessable baseline sleep status; Subjects deemed unlikely to complete key data collection or follow-up at the investigator's discretion.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy
|
Standard elective video-assisted thoracoscopic (VATS) lobectomy or segmentectomy with general anesthesia and one-lung ventilation, performed according to routine institutional protocols.
This is an observational study; no experimental modification is made to the surgical procedure, anesthetic management, or postoperative care.
Patients receive standard thoracic ERAS care including analgesia, chest tube management, and vital sign monitoring.
The procedure provides the clinical context for prospective perioperative data collection to develop dynamic prediction models for first-night sleep disturbance and analyze ward workflow impacts.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomy
Tidsramme: From PACU return to the general thoracic ward until 06:00 on postoperative day 1, assessed on the morning of postoperative day 1
|
Clinically significant postoperative sleep disturbance (PSD) assessed by the Richards-Campbell Sleep Questionnaire (RCSQ) on postoperative day 1 morning.
RCSQ contains 5 items (sleep depth, latency, awakenings, return to sleep, overall quality) scored 0-100; total score is the mean (higher=better).
PSD defined as RCSQ total ≤50.
First postoperative night: from PACU return to 06:00 next day (or actual return time if after 22:00).
One missing item: mean of remaining four; ≥2 missing or inability to complete due to delirium/cognitive/communication barriers: invalid.
|
From PACU return to the general thoracic ward until 06:00 on postoperative day 1, assessed on the morning of postoperative day 1
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
23. juli 2026
Primær fullføring (Antatt)
22. juli 2027
Studiet fullført (Antatt)
30. oktober 2027
Datoer for studieregistrering
Først innsendt
16. juli 2026
Først innsendt som oppfylte QC-kriteriene
16. juli 2026
Først lagt ut (Faktiske)
21. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KY-2026-165
Plan for individuelle deltakerdata (IPD)
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NEI
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