Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07432607

High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery

Led by Ebru Girgin Dinc · Updated on 2026-05-05

60

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, randomized, parallel-group clinical trial designed to evaluate the effects of high-flow nasal oxygen therapy (HFNOT) versus conventional oxygen mask (COM) on perioperative hypoxia in patients undergoing video-assisted thoracoscopic (VATS) pericardial window procedures under sedoanalgesia. The pericardial window procedure, indicated for diagnostic and therapeutic drainage of pericardial effusion, is traditionally performed under general anesthesia. However, the use of non-intubated VATS with sedoanalgesia has gained popularity due to reduced morbidity, shorter recovery, and avoidance of complications associated with general anesthesia, especially in elderly and comorbid patients. During non-intubated VATS, the occurrence of hypoxia and hemodynamic instability may be exacerbated by procedural pneumothorax and underlying cardiac pathology. High-flow nasal oxygen therapy may provide physiological benefits in this setting by reducing airway resistance, improving alveolar ventilation, and minimizing dead space. The primary outcome of the study is to compare the incidence of perioperative hypoxia between HFNOT and COM groups. Secondary outcomes include patient comfort, intraoperative oxygenation profiles, hemodynamic stability, and recovery parameters. The trial will be conducted at a single academic center with eligible patients randomized into two treatment arms.

CONDITIONS

Official Title

High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 75 years
  • Scheduled for elective video-assisted thoracoscopic pericardial window procedure under sedoanalgesia
  • ASA Physical Status Classification I-III
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Age less than 18 or greater than 75 years
  • ASA Physical Status IV or higher
  • Body Mass Index greater than 30 kg/m2
  • Need for inotropic support at enrollment
  • Preoperative hemodynamic instability
  • Symptomatic respiratory disease such as pneumonia, nasal congestion, or asthma attack
  • Diagnosed neuromuscular disorder
  • Diagnosed tracheal stenosis
  • Local infection at the site of regional block application
  • Coagulopathy or bleeding diathesis
  • Pregnancy
  • Patients refusing sedoanalgesia
  • Patients refusing study participation
  • Conversion to general anesthesia or use of supraglottic airway intraoperatively

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Kosuyolu Heart Training and Research Hospital

Istanbul, KARTAL, Turkey (Türkiye), 34860

Actively Recruiting

Loading map...

Research Team

E

Ebru GIRGIN DINC, MD

CONTACT

E

Esin ERDEM, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery | DecenTrialz