An observational study in Pericardial Effusion, Inflammatory Response After Surgery and Postoperative Complications, sponsored by Koşuyolu Kartal Heart Training and Research Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Koşuyolu Kartal Heart Training and Research Hospital · Observational
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.
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.
29 studies on the registry are indexed under Pericardial Effusion; 5 are open to participants now.
Browse Pericardial Effusion studies →Koşuyolu Kartal Heart Training and Research Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Procedural sedation with systemic opioid analgesia, administered as part of routine clinical care. No intervention was assigned by the investigators.
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.
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.
Time frame: From within 24 hours before surgery to the morning of postoperative day 1 (06:00-10:00)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From day of surgery to hospital discharge, up to 30 days
Plan to share: 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.
Supporting information: Statistical analysis plan, Clinical study report
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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Koşuyolu Kartal Heart Training and Research Hospital