Water Seal vs. Suction for Collapsed Lung

(SEAL IT Trial)

Overseen By Allan B Peetz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnant, Prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the effect of placing chest tubes to water seal versus suction initially, in patients with traumatic pneumothoraces, on overall chest tube duration. The main question it aims to answer is: * Does placing chest tubes to water seal initially results in a shorter chest tube duration, without an increase in complications? Alternating each month, patients' chest tubes will either be placed to water seal or to suction initially. All other management decisions related to the chest tube will be left to the providers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Water Seal vs. Suction for Collapsed Lung?

Research on suction therapy in emergency and intensive care settings highlights its importance in maintaining open airways and reducing complications when performed as needed rather than routinely. This suggests that careful assessment and application of suction could be beneficial in managing collapsed lungs. ^{1 2 3 4 5}

Is it safe to use water seal or suction for managing chest tubes in humans?

Research shows that both water seal and suction methods are generally safe for managing chest tubes after lung surgery, with some studies suggesting that water seal may lead to quicker recovery and less hospital time. ^{6 7 8 9 10}

How does the water seal treatment for a collapsed lung differ from other treatments?

The water seal treatment for a collapsed lung involves managing chest tubes without applying suction, which may lead to quicker removal of the tubes and a shorter hospital stay compared to using suction. This approach is unique because it focuses on allowing the lung to heal naturally without the added pressure from suction, potentially reducing complications like prolonged air leaks. ^{6 7 8 9 11}

Eligibility Criteria

This trial is for adults with a collapsed lung due to trauma who need a chest tube and are under the care of the trauma surgery service. It's not for those under 18, pregnant women, prisoners, or patients with over 300cc of blood in the chest or a chest tube placed before CT scans.

Inclusion Criteria

I have had a collapsed lung treated with a chest tube.

I am under the care of the trauma surgery team.

Exclusion Criteria

Pregnant

Prisoner

Greater than 300cc of hemothorax on CT

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Chest tubes are placed to water seal or suction initially, alternating each month

Duration varies per patient

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness after chest tube placement

1 year

Regular monitoring through study completion

Treatment Details

Interventions

• Inital water seal
• Initial suction

Trial Overview The SUC IT trial is testing whether starting with a water seal rather than suction on chest tubes can reduce how long patients need them after traumatic pneumothorax without increasing complications. The method used alternates monthly.

Participant Groups

Group I: Initial Water Seal Experimental Treatment 1 Intervention

After chest tube placement, the chest tube will be placed to 20cm H2O of suction for 1 minute to evacuate all pneumothorax. After this, the chest tube will be placed to water seal, defined as the water seal chamber on the chest tube drainage system being filled up to the 2cm line and not on suction. All other management decisions related to the chest tube will be left to the providers.

Group II: Initial Suction Experimental Treatment 1 Intervention

After chest tube placement, the suction group will have their chest tube placed to 20cm H2O of suction delivered by the chest tube drainage suction. All other management decisions related to the chest tube will be left to the providers.

Inital water seal is already approved in United States for the following indications:

Approved in United States as Initial Water Seal for:

• Traumatic Pneumothorax

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

In a randomized clinical trial involving 20 patients, there was no significant difference in the incidence of ventilator-associated pneumonia (VAP) between those receiving open-suction (12 patients) and closed-suction (8 patients) methods (p = 0.4).

Factors such as Acute Physiology and Chronic Health Evaluation II scores, duration of intubation, and steroid use did not show significant differences, suggesting that suctioning method may not impact VAP rates, but further studies with larger sample sizes are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Incidence of ventilator-associated pneumonia in patients using open-suction systems and closed-suction systems: a prospective study -- preliminary data]. Zeitoun, SS., de Barros, AL., Diccini, S., et al.[2019]

A controlled study in an Intensive Care Unit showed that endotracheal suctioning based on patient assessment resulted in significantly better outcomes and fewer complications compared to routine suctioning every 2 hours.

Patients who received suctioning only when needed had improved measures such as peak airway pressures, heart rate, and mean arterial pressure, suggesting that tailored suctioning practices may enhance patient safety and efficacy in short-term ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can nurses safely assess the need for endotracheal suction in short-term ventilated patients, instead of using routine techniques? Wood, CJ.[2019]

Suction therapy is a critical part of airway management in emergency care, and all staff must be trained in safe suctioning techniques to prevent complications.

The paper emphasizes the need for standardization in suction catheter use to minimize risks and improve patient safety, as suctioning can lead to respiratory, cardiovascular, and other complications if not performed correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based suction management in accident and emergency: a vital component of airway care. Dean, B.[2019]

A systematic review of 17 randomized controlled trials on endotracheal suctioning in critically ill adults revealed six key intervention categories that impact patient outcomes, including hemodynamic changes and infection rates.

Despite the relevance of the findings for clinical practice, the presence of significant bias in the studies limits the reliability of the evidence regarding the best practices for suctioning in mechanically ventilated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endotracheal suction in intubated critically ill adult patients undergoing mechanical ventilation: a systematic review. Favretto, DO., Silveira, RC., Canini, SR., et al.[2019]

In a study involving 90 children in the Pediatric Intensive Care Unit, no significant differences were found between an as-needed endotracheal suctioning protocol and a routine suctioning protocol regarding complications like hypoxemia and arrhythmias.

Both suctioning methods resulted in similar rates of adverse events, indicating that the as-needed approach may be as safe and effective as the routine method for managing ventilated children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

As-needed endotracheal suctioning protocol vs a routine endotracheal suctioning in Pediatric Intensive Care Unit: A randomized controlled trial. Lema-Zuluaga, GL., Fernandez-Laverde, M., Correa-Varela, AM., et al.[2022]

In a study of 68 patients who underwent pulmonary resection, using a water seal for chest tubes after an initial suction period significantly reduced the duration of air leaks compared to continuous suction, with an average of 1.50 days versus 3.27 days (p = 0.05).

Patients in the water seal group also had a shorter mean time to chest tube removal (3.33 days) compared to the suction group (5.47 days), suggesting that this method may lead to lower morbidity and hospital costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suction vs water seal after pulmonary resection: a randomized prospective study. Marshall, MB., Deeb, ME., Bleier, JI., et al.[2022]

In a systematic review of 7 randomized controlled trials involving patients undergoing pulmonary surgery, there was no significant difference in the duration of air leaks or hospital stay between using suction with water seal and water seal alone for chest tubes.

While suction with water seal did not improve air leak outcomes, it was associated with a lower incidence of postoperative pneumothorax, although the clinical importance of this finding remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chest tubes after pulmonary resection: a systematic review and meta-analysis. Coughlin, SM., Emmerton-Coughlin, HM., Malthaner, R.[2022]

In a study of 80 trauma patients, both suction and water-seal methods for chest tube removal were found to be equally effective, with similar rates of recurrent pneumothorax (2.5%).

The suction method significantly reduced the total time the chest tube was in place (72.2 hours vs. 92.5 hours) and the time to remove the tube after air leak resolution (25.2 hours vs. 35.6 hours), suggesting it may lead to shorter hospital stays for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized study of algorithms for discontinuing tube thoracostomy drainage. Davis, JW., Mackersie, RC., Hoyt, DB., et al.[2006]

In a study of 109 patients who underwent lobectomy or segmentectomy, using a water seal for chest tube management after surgery significantly reduced the duration of chest tube placement and hospital stay compared to suction management.

For patients without an air leak, those managed with a water seal had chest tubes removed on average by postoperative day 3.19 and were discharged by day 5.13, while those on suction had tubes removed by day 4.52 and were discharged by day 6.74, highlighting the benefits of water seal management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial chest tube management after pulmonary resection. Antanavicius, G., Lamb, J., Papasavas, P., et al.[2022]

In a study of 52 children undergoing elective thoracic surgery, removing chest tubes directly from suction without a water seal trial was found to be safe, with no major pleural effusions occurring post-removal.

While there was a higher incidence of pneumothorax in the water seal group (33%) compared to the suction group (11%), the overall difference was not statistically significant, suggesting that omitting the water seal may allow for earlier and safer chest tube removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Removal of chest tubes in children without water seal after elective thoracic procedures: a randomized prospective study. Waldhausen, JH., Cusick, RA., Graham, DD., et al.[2019]

In a study of 145 patients who underwent pulmonary lobectomy, using chest tubes on water seal did not significantly reduce the duration of air leaks compared to continuous suction, with both groups experiencing similar air leak durations (6.5 vs 6.3 days).

Patients with chest tubes on water seal experienced a higher rate of postoperative complications (31.9%) compared to those on suction (17.8%), suggesting that while water seal is safe, it may not be the best option for minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of water seal and suction after pulmonary lobectomy: a prospective, randomized trial. Brunelli, A., Monteverde, M., Borri, A., et al.[2022]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Incidence of ventilator-associated pneumonia in patients using open-suction systems and closed-suction systems: a prospective study -- preliminary data]. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Can nurses safely assess the need for endotracheal suction in short-term ventilated patients, instead of using routine techniques? [2019]

3. England pubmed.ncbi.nlm.nih.gov

Evidence-based suction management in accident and emergency: a vital component of airway care. [2019]

4. Brazil pubmed.ncbi.nlm.nih.gov

Endotracheal suction in intubated critically ill adult patients undergoing mechanical ventilation: a systematic review. [2019]

5. Colombia pubmed.ncbi.nlm.nih.gov

As-needed endotracheal suctioning protocol vs a routine endotracheal suctioning in Pediatric Intensive Care Unit: A randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Suction vs water seal after pulmonary resection: a randomized prospective study. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Management of chest tubes after pulmonary resection: a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized study of algorithms for discontinuing tube thoracostomy drainage. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Initial chest tube management after pulmonary resection. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Removal of chest tubes in children without water seal after elective thoracic procedures: a randomized prospective study. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of water seal and suction after pulmonary lobectomy: a prospective, randomized trial. [2022]