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Dynamic Prediction of Sleep Protection Demand on the First Postoperative Night and Its Influence on Ward Process After Thoracoscopic Lobectomy or Segmentectomy

Dynamic Prediction of First-Night Sleep Protection Needs After Thoracoscopic Lobectomy/Segmentectomy and Analysis of the Impact of Ward Routines

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07716085
Enrollment
400
Registered
2026-07-21
Start date
2026-07-23
Completion date
2027-10-30
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Sleep Disturbance

Keywords

postoperative sleep disturbance, video-assisted thoracoscopic (VATS) lobectomy/segmentectomy, dynamic prediction model, ward workflow burden

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREVideo-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.

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomyFrom PACU return to the general thoracic ward until 06:00 on postoperative day 1, assessed on the morning of postoperative day 1Clinically 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.

Contacts

CONTACTRuishi Yuan
police1872@163.com+86 18726732268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026