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OpenTrials
Completed

NCT Number: NCT06144398

Single Use Flexible Bronchoscopes in Interventional Pulmonary Procedures

Single Use Flexible bronchoscopes have gained popularity in recent years and are becoming technologically more advanced. They are widely accepted and used in everyday practice for simple procedures. The aim of this study is to evaluate single use flexible bronchoscopes in more advanced settings, such as interventional pulmonary procedures.

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Key information

Conditions

Atelectasis Hemoptysis Hemorrhage Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Atelectasis Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Stridor

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients requiring an interventional pulmonary procedure during the study period
  • Signed informed consent

Exclusion criteria

  • Any patient with a contraindication for rigid and/or flexible bronchoscopy
  • Coagulopathy (PV INR > 1.3)
  • Thrombocytopenia (<50x10*9 or anemia (Hgb <80 g/L)
  • DOAC, LMWH or antiplatelet drug therapy
  • Thrombophilia, history of pulmonary embolism or deep vein thrombosis
  • Contraindication for endobronchial application of adrenaline
  • Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
  • Uncontrolled pulmonary hypertension
  • Cardiovascular decompensation
  • Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)
  • Cervical spine instability

Treatment and study plan

Single use bronchoscope

Device

The interventional procedure is performed with a single use bronchoscope.

Standard Bronchoscope

Device

The interventional procedure is performed with a standard bronchoscope.

Primary outcomes

  1. Overall performance

    Time frame: through study completion, an average of 12 months

    Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

Secondary outcomes

  1. Functionality, handle and interface

    Time frame: through study completion, an average of 12 months

    Functionality, handle and interface of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

  2. Suction

    Time frame: through study completion, an average of 12 months

    Suction power of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

  3. Image quality

    Time frame: through study completion, an average of 12 months

    Image quality as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

  4. Bleeding control

    Time frame: through study completion, an average of 12 months

    Bleeding control as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

  5. Compatibility

    Time frame: through study completion, an average of 12 months

    Compatibility with other devices (i.e. ballon blockers, forceps, laser, cryprobe) as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)

Sponsors and collaborators

Lead sponsor

Clinical Hospital Centre Zagreb

Other

Registry information

Official study title

Single Use Versus Standard Flexible Bronchoscopes in Interventional Pulmonary Procedures: an Open Label Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 22, 2023
Registry last updated
Aug 6, 2024

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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