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

NCT07716085 | Not Yet Recruiting

• 1 other identifier: KY-2026-165
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Sleep Disturbance

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy

Procedure: Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy

Interventions

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.

Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Interventions

Thoracic Surgery, Video-Assisted; Mastectomy, Segmental

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Mastectomy

Central Study Contacts

Ruishi Yuan

CONTACT

+86 18726732268; police1872@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share