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NCT Number: NCT07800767

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pericardial Effusion Agnosia Cardiovascular Diseases Heart Diseases Inflammatory Response After Surgery Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Non-intubated Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Procedural Sedation and Analgesia Signs and Symptoms Video Assisted Thoracic Surgery (VATS)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kosuyolu Heart Training and Research Hospital

Istanbul, Kartal, 34862, Turkey (Türkiye)

About this study

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 cardiovascular training and research hospital. Patients will be classified into two predefined groups according to the anaesthesia management module documented in their perioperative records. The primary outcome is the change in the neutrophil-to-lymphocyte ratio (NLR) from before surgery to the morning of postoperative day 1. Secondary outcomes address ERAS-related endpoints, including discharge within postoperative day 1, intensive care admission, hospital length of stay, analgesic and antiemetic requirements, and postoperative complications. The ability of each anaesthesia management module to sustain the planned non-intubated technique through to the end of surgery is also assessed. No intervention is assigned by the investigators. All data are obtained from existing clinical records, and no additional test, procedure, or contact with patients is involved.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in neutrophil-to-lymphocyte ratio (delta NLR)

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

    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.

Secondary outcomes

  1. Postoperative respiratory support requirement

    Time frame: From end of surgery to hospital discharge, up to 30 days

    Proportion of patients requiring facemask ventilation, non-invasive mechanical ventilation, or invasive mechanical ventilation after surgery, recorded as yes or no.

  2. Failure to sustain the planned non-intubated technique

    Time frame: From induction of sedation to end of surgery

    Proportion of patients in whom the anaesthesia management module initiated at the start of the procedure could not be sustained to the end of surgery. Defined hierarchically: (a) conversion to tracheal intubation; (b) any airway or ventilatory support, comprising facemask ventilation, supraglottic airway placement, or tracheal intubation.

  3. Early postoperative change in neutrophil-to-lymphocyte ratio

    Time frame: From the end of surgery to the 6th hour postoperatively

    Delta NLR calculated using the first postoperative day 0 complete blood count instead of the postoperative day 1 sample, restricted to samples drawn within 0-6 hours after the end of surgery.

  4. C-reactive protein on postoperative day 1

    Time frame: Up to the morning of postoperative day 1

    Serum C-reactive protein concentration in mg/L, from the routine morning biochemistry panel on postoperative day 1.

  5. Intensive care unit length of stay

    Time frame: From end of surgery to hospital discharge, up to 30 days

    Duration of intensive care unit stay in days, for patients admitted to intensive care.

  6. Hospital length of stay

    Time frame: From day of surgery to hospital discharge, up to 30 days

    Total duration of hospital stay in days, from the day of surgery to the day of discharge.

Sponsors and collaborators

Lead sponsor

Koşuyolu Kartal Heart Training and Research Hospital

Other

Registry information

Official study title

Effect of Different Anesthesia Management Approaches on Inflammatory Response and Enhanced Postoperative Recovery Outcomes in Non Intubated Video-assisted Thoracoscopic Surgery: A Single-centre Retrospective Cohort Study

Acronym: RNIVATS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 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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