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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07800767
Acronym
RNIVATS
Enrollment
120
Registered
2026-09-02
Start date
2026-08-30
Completion date
2026-12-30
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

OTHERSystemic opioid-based analgesia during NIVATS

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

PROCEDUREThoracic regional analgesia during NIVATS

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.

Sponsors

Koşuyolu Kartal Heart Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in neutrophil-to-lymphocyte ratio (delta NLR)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

MeasureTime frameDescription
Early postoperative change in neutrophil-to-lymphocyte ratioFrom the end of surgery to the 6th hour postoperativelyDelta 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.
C-reactive protein on postoperative day 1Up to the morning of postoperative day 1Serum C-reactive protein concentration in mg/L, from the routine morning biochemistry panel on postoperative day 1.
Failure to sustain the planned non-intubated techniqueFrom induction of sedation to end of surgeryProportion 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.
Hospital length of stayFrom day of surgery to hospital discharge, up to 30 daysTotal duration of hospital stay in days, from the day of surgery to the day of discharge.
Postoperative respiratory support requirementFrom end of surgery to hospital discharge, up to 30 daysProportion of patients requiring facemask ventilation, non-invasive mechanical ventilation, or invasive mechanical ventilation after surgery, recorded as yes or no.
Intensive care unit length of stayFrom end of surgery to hospital discharge, up to 30 daysDuration of intensive care unit stay in days, for patients admitted to intensive care.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026