Anesthesia Management, Inflammatory Response and Recovery After Non-intubated VATS Pericardial Window

NCT07800767 | Active Not Recruiting

• 1 other identifier: RNIVATS-S001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Non-intubated video-assisted thoracoscopic surgery (NIVATS) is performed under spontaneous ventilation and avoids tracheal intubation and one-lung mechanical ventilation. It is increasingly used for the surgical management of pericardial effusion, where a pericardial window is created thoracoscopically. Because NIVATS avoids airway instrumentation and positive-pressure ventilation, it has been proposed to blunt the perioperative inflammatory and stress response and to support enhanced recovery after surgery targets. Within NIVATS, anaesthetic management is not uniform. In routine institutional practice, some patients are managed with procedural sedation plus systemic opioid analgesia, while others receive procedural sedation plus a thoracic regional analgesia technique. Whether this difference in analgesic strategy translates into a measurable difference in the systemic inflammatory response or in early recovery outcomes has not been established. This single-centre retrospective cohort study will review the records of adult patients who underwent NIVATS pericardial window creation for pericardial effusion at a tertiary hospital.

Conditions

Pericardial Effusion; Inflammatory Response After Surgery; Postoperative Complications; Video Assisted Thoracic Surgery (VATS); Non-intubated Anesthesia; Procedural Sedation and Analgesia

Keywords

Neutrophil-to-lymphocyte ratio; Non-intubated video-assisted thoracoscopic surgery; NIVATS; Pericardial window; pericardial effusion; Procedural Sedation; Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

• Change in neutrophil-to-lymphocyte ratio (delta NLR)

  NLR is calculated from the routine complete blood count as the absolute neutrophil count divided by the absolute lymphocyte count (dimensionless ratio). Delta NLR is calculated for each patient as postoperative NLR minus preoperative NLR. The preoperative value is taken from the complete blood count closest to and within 24 hours before surgery. The postoperative value is taken from the routine morning complete blood count on postoperative day 1, sampled between 06:00 and 10:00. A larger positive value indicates a greater postoperative inflammatory response. Delta NLR will be compared between the two anaesthesia management groups.

  From within 24 hours before surgery to the morning of postoperative day 1 (06:00-10:00)

Secondary Outcomes (6)

• Postoperative respiratory support requirement

  From end of surgery to hospital discharge, up to 30 days

• Failure to sustain the planned non-intubated technique

  From induction of sedation to end of surgery

• Early postoperative change in neutrophil-to-lymphocyte ratio

  From the end of surgery to the 6th hour postoperatively

• C-reactive protein on postoperative day 1

  Up to the morning of postoperative day 1

• Intensive care unit length of stay

  From end of surgery to hospital discharge, up to 30 days

Study Arms (2)

Sedation with systemic opioid analgesia

Patients whose documented anaesthesia management module consisted of procedural sedation combined with systemic opioid analgesia, without a thoracic regional analgesia technique. Patients are assigned to this group according to the module planned and initiated at the start of the procedure.

Procedure: Thoracic regional analgesia during NIVATS

Sedation with thoracic regional analgesia

Patients whose documented anaesthesia management module consisted of procedural sedation combined with a thoracic regional analgesia technique: paravertebral block, erector spinae plane block, or serratus anterior/intercostal plane block. Patients are assigned to this group according to the module planned and initiated at the start of the procedure.

Other: Systemic opioid-based analgesia during NIVATS

Interventions

Systemic opioid-based analgesia during NIVATS OTHER

Procedural sedation with systemic opioid analgesia, administered as part of routine clinical care. No intervention was assigned by the investigators.

Sedation with thoracic regional analgesia

Thoracic regional analgesia during NIVATS PROCEDURE

Procedural sedation combined with paravertebral block, erector spinae plane block, or serratus anterior/intercostal plane block, administered as part of routine clinical care. No intervention was assigned by the investigators.

Sedation with systemic opioid analgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients who underwent non-intubated (spontaneous ventilation) video-assisted thoracoscopic creation of a pericardial window for pericardial effusion at a single tertiary cardiovascular training and research hospital. All eligible cases identified in the hospital records within this period will be included; no sampling or selection beyond the eligibility criteria will be applied.

You may qualify if:

• Adults aged 18 to 80 years
• Underwent non-intubated video-assisted thoracoscopic surgery with spontaneous ventilation for creation of a pericardial window for pericardial effusion at the study centre
• American Society of Anesthesiologists (ASA) physical status I to IV
• Available preoperative complete blood count within 24 hours before surgery and routine morning complete blood count on postoperative day 1
• Anaesthesia management module classifiable as Group A or Group B from the perioperative records

You may not qualify if:

• Age under 18 years or over 80 years
• Pregnancy
• Documented poor general condition or haemodynamic instability before surgery
• Requirement for inotropic or vasopressor support before surgery
• Intensive care unit stay exceeding 24 hours before surgery
• Missing preoperative or postoperative day 1 complete blood count
• Haematological malignancy, active systemic infection, or ongoing corticosteroid or immunosuppressive therapy at the time of surgery
• Anaesthesia management not classifiable into either predefined module

Sponsors & Collaborators

• Koşuyolu Kartal Heart Training and Research Hospital: lead

Study Sites (1)

Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, 34862, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pericardial Effusion; Postoperative Complications; Agnosia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 2, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Beginning 6 months after publication of the primary results and ending 3 years thereafter.
• Access Criteria: Requests should be directed to the principal investigator. Data will be released subject to approval by the institutional ethics committee.

Locations

TU (1)