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Completed

NCT Number: NCT06036667

Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS

The aim of the study is to evaluate efficacy and safety of "Smart Coaxial drain" (Redax TM, Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper lobectomies.

In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.

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Key information

Conditions

Pleural Effusion Chest Tubes Pleural Diseases Respiratory Tract Diseases Video Assisted Thoracic Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

About this study

At the end of lung surgery, usually surgeons placed one or more chest tubes. There are several types of chest tubes and the type used by surgeons depends on centre avaiability/ local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr "coaxial smart drain" chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS upper lobectomies in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's confort.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS

Exclusion criteria

  • Patients undergone open surgery
  • Patients undergone middle or lower lobectomies
  • Patients undergone chest wall/or wedge resections

Treatment and study plan

28Fr "coaxial smart drain" chest tube

Procedure

To evaluate the efficacy of one 28Fr chest tube ("coaxial smart drain" versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon's choice etc) after Uniportal- or Biportal-VATS upper lobectomies.

Primary outcomes

  1. Fluid output 1

    Time frame: At 24 hours from surgery

    Total fluid amount

  2. Fluid output 2

    Time frame: At 48 hours from surgery

    Total fluid amount

  3. Fluid output 3

    Time frame: At 72 hours from surgery

    Total fluid amount

  4. Fluid output 4

    Time frame: At 96 hours from surgery

    Total fluid amount

  5. Residual pleural effusion at chest X-Ray

    Time frame: 72 hours after surgery

    Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as "intercostal spaces", counted on posterior costal arches

  6. subcutaneous emphysema 1

    Time frame: At 24 hours after surgery

    incidence of subcutaneous emphysema

  7. subcutaneous emphysema 2

    Time frame: At 48 hours after surgery

    incidence of subcutaneous emphysema

  8. subcutaneous emphysema 3

    Time frame: At 72 hours after surgery

    incidence of subcutaneous emphysema

Secondary outcomes

  1. Tube obstruction

    Time frame: during chest tube removal procedure

    tube obstructed by blood clots

  2. Pain related to chest tube 1

    Time frame: At 24 hours after surgery

    Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)

  3. Pain related to chest tube 2

    Time frame: At 48 hours after surgery

    Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)

  4. Pain related to chest tube 3

    Time frame: At 72 hours after surgery

    Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)

  5. Pain related to chest tube 4

    Time frame: At 96 hours after surgery

    Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS>4 and <10 indicates moderate to severe pain)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2023
Registry last updated
Feb 28, 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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