Duration of Chest Tube Suction in Traumatic Pneumothorax

NCT ID: NCT04986527

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-05-01

Brief Summary

The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax.

Conditions

Traumatic Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

24 hours of suction

Subjects with chest tubes kept to -20 cmH2O suction for 24 hours prior to water seal

Group Type: ACTIVE_COMPARATOR

Chest tube suction

Intervention Type: PROCEDURE

The chest tubes will be inserted using our institutional standard chest tube insertion tray. The chest tubes used will be our institutional standard and will range from 14 to 32Fr in size. After chest tube placement, an Atrium Oasis Dry Suction Water Seal Chest Drain (Getinge USA Sales, LLC) will be used.

48 hours of suction

Subjects with chest tubes kept to -20 cmH2O suction for 48 hours prior to water seal

Group Type: EXPERIMENTAL

Chest tube suction

Intervention Type: PROCEDURE

The chest tubes will be inserted using our institutional standard chest tube insertion tray. The chest tubes used will be our institutional standard and will range from 14 to 32Fr in size. After chest tube placement, an Atrium Oasis Dry Suction Water Seal Chest Drain (Getinge USA Sales, LLC) will be used.

Interventions

Chest tube suction

The chest tubes will be inserted using our institutional standard chest tube insertion tray. The chest tubes used will be our institutional standard and will range from 14 to 32Fr in size. After chest tube placement, an Atrium Oasis Dry Suction Water Seal Chest Drain (Getinge USA Sales, LLC) will be used.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Trauma service consult/patient
• Traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position
• Age >18
• Blunt or penetrating mechanism
• Chest tubes sizes 14 to 32Fr
• Chest tubes placed by residents on the trauma surgery service supervised by attending trauma surgeons or placed by the attending surgeon themselves
• Presence of single chest tube in one or both pleural cavities (single unilateral or bilateral tubes)
• Subjects with decision making capacity (DMC) who are able to provide written consent. DMC will be determined by the consenting physician through a teach back mechanism. Subjects must demonstrate understanding of the situation, appreciation of the consequences of their decision, reasoning of their thought process, and be able to communicate their wishes.

Exclusion Criteria

• Age <18
• Pregnant patients
• Prisoners
• Mechanically ventilated in ICU for more than 24 hours while chest tube in place
• Chest tubes placed as part of, or present during, a thoracic operation
• History of surgery involving pleural cavity ipsilateral to chest tube
• Subjects with more than one chest tube on the ipsilateral side at any time prior to study chest tube removal
• Subjects with chylothorax or empyema
• Subjects with chest tubes that are withdrawn or removed unintentionally
• Subjects with known or suspected bronchial injury
• Subjects with bullous emphysema.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Michael J Nabozny, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

STUDY00005364

Identifier Type: -

Identifier Source: org_study_id