Pericardial EffusionRNIVATSNCT07800767
Anesthesia Management, Inflammatory Response and Recovery After Non-intubated VATS Pericardial Window
An observational study of Pericardial Effusion and Inflammatory Response After Surgery, run by Koşuyolu Kartal Heart Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pericardial Effusion, Inflammatory Response After Surgery, Postoperative Complications
- What is being tested?
- Systemic opioid-based analgesia during NIVATS and Thoracic regional analgesia during NIVATS
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 30 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kosuyolu Heart Training and Research Hospital
Istanbul, Kartal, 34862
About this study
Official 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
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.
Read the 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.
- Conditions
- Pericardial Effusion, Inflammatory Response After Surgery, Postoperative Complications, Procedural Sedation and Analgesia, Video Assisted Thoracic Surgery (VATS), Non-intubated Anesthesia
- Being tested
- Systemic opioid-based analgesia during NIVATS, Thoracic regional analgesia during NIVATS
- Keywords
- Neutrophil-to-lymphocyte ratio, Non-intubated video-assisted thoracoscopic surgery, NIVATS, Pericardial window, pericardial effusion, Procedural Sedation, Enhanced recovery after surgery
- Medical subject headings
- Pericardial Effusion, Postoperative Complications, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic opioid-based analgesia during NIVATSOther
Procedural sedation with systemic opioid analgesia, administered as part of routine clinical care. No intervention was assigned by the investigators.
Thoracic regional analgesia during NIVATSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Systemic opioid-based analgesia during NIVATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From within 24 hours before surgery to the morning of postoperative day 1 (06:00-10:00)
Secondary outcomes (6)
Postoperative respiratory support requirement
Proportion of patients requiring facemask ventilation, non-invasive mechanical ventilation, or invasive mechanical ventilation after surgery, recorded as yes or no.
Measured: From end of surgery to hospital discharge, up to 30 days
Failure to sustain the planned non-intubated technique
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.
Measured: From induction of sedation to end of surgery
Early postoperative change in neutrophil-to-lymphocyte ratio
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.
Measured: From the end of surgery to the 6th hour postoperatively
C-reactive protein on postoperative day 1
Serum C-reactive protein concentration in mg/L, from the routine morning biochemistry panel on postoperative day 1.
Measured: Up to the morning of postoperative day 1
Intensive care unit length of stay
Duration of intensive care unit stay in days, for patients admitted to intensive care.
Measured: From end of surgery to hospital discharge, up to 30 days
Hospital length of stay
Total duration of hospital stay in days, from the day of surgery to the day of discharge.
Measured: From day of surgery to hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start30 Aug 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericardial EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koşuyolu Kartal Heart Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Girgin Dinc, Koşuyolu Kartal Heart Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800767
- Sponsor's protocol ID
- RNIVATS-S001
- Acronym
- RNIVATS
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results may be made available following completion of the study. The dataset will contain no direct identifiers. Dates will be provided as intervals rather than calendar dates and age will be provided in bands, to limit re-identification risk in this single-centre cohort.