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Completed

NCT Number: NCT02344524

Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain

The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.

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Key information

Conditions

Traumatic Hemothorax and Pneumothorax Pleural Diseases Pneumothorax Respiratory Tract Diseases

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College of Medical Sciences & GTB Hospital

New Delhi, National Capital Territory of Delhi, 110095, India

About this study

The precise role of small bore chest drains in treating post traumatic pleural collections, especially hemothorax is not well established. This trial is conducted to study the efficacy and safety profile of small bore chest drains in trauma patients with hemothorax and pneumothorax.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with traumatic hemothorax, pneumothorax and hemopneumothorax

Exclusion criteria

  • Patients with tension pneumothorax
  • Patients requiring emergency thoracotomy
  • Patients who had undergone chest drain insertion elsewhere
  • Patients lost to follow up

Treatment and study plan

Intercostal drainage

Device

Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.

Primary outcomes

  1. Success rate

    Time frame: 7 days (plus or minus 5 days)

    Complete drainage of traumatic hemothorax and pneumothorax

Secondary outcomes

  1. Procedure time

    Time frame: At the time of the intervention

    Time taken for inserting the chest drain

  2. Iatrogenic injuries

    Time frame: At the time of the intervention

    Insertion related complications

  3. Resolution time

    Time frame: 7 days (plus or minus 5 days)

    Time taken for complete drainage of traumatic hemothorax and pneumothorax

  4. Wound healing time

    Time frame: 10 days (plus or minus 5 days)

    Time taken for the chest drain site wound to heal

  5. Catheter sepsis

    Time frame: 7 days (plus or minus 5 days)

    Identification of infective organisms from catheter tip based on culture following chest drain removal

Sponsors and collaborators

Lead sponsor

Delhi University

Other

Registry information

Official study title

Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

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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