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NCT Number: NCT07716085

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

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.

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Key information

Conditions

Postoperative Sleep Disturbance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy

Procedure

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.

Primary outcomes

  1. Clinically significant postoperative sleep disturbance on the first night after VATS lobectomy or segmentectomy

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruishi Yuan

CONTACT

[email protected]

+86 18726732268

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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