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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy

    Procedure/Surgery

    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.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Video-assisted thoracoscopic (VATS) lobectomy or segmentectomy1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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