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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to manage chest tubes in patients with a collapsed lung due to trauma. Specifically, it compares whether using a water seal or suction initially results in a shorter duration with the chest tube, without increasing complications. Each month, participants will be randomly assigned to either the water seal or suction method. This trial suits those with a traumatic pneumothorax who require a chest tube and are admitted to the trauma surgery service. As an unphased trial, it offers participants the chance to contribute to important research that could enhance future treatment methods for traumatic pneumothorax.

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 prior data suggests that these methods are safe for treating collapsed lungs?

Research has shown that both the water seal and suction methods are generally safe for managing chest tubes after a lung collapse. Studies suggest that a water seal can be as safe and effective as low suction in reducing air leaks and shortening the duration of chest tube use. In one study, 22% of patients using a water seal experienced a recurring pneumothorax, a known risk.

For the suction method, research indicates it is safe and may help the lung re-expand faster, potentially reducing the time a chest tube is needed. However, chest tubes can sometimes cause complications, such as incorrect placement or infections, regardless of the method used. Both treatments have their pros and cons, but they are considered safe overall for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different methods for managing a collapsed lung: the initial water seal approach and the initial suction approach. Typically, treatments for a collapsed lung involve using chest tubes with suction to help re-expand the lung. However, the water seal method provides an intriguing alternative by potentially reducing the reliance on continuous suction, which can be uncomfortable for patients. By comparing these two techniques, researchers hope to discover if the water seal can offer a more comfortable, yet equally effective, option for patients. This could lead to a shift in how collapsed lungs are managed, focusing more on patient comfort without compromising on treatment outcomes.

What evidence suggests that this trial's treatments could be effective for traumatic pneumothoraces?

This trial will compare the effectiveness of two methods for managing chest tubes after a lung collapse: the Initial Water Seal and Initial Suction. Research has shown that both water seal and suction methods are generally safe. Some studies have found that a water seal can be as effective as low suction in reducing air leaks and the duration of chest tube use. A thorough review found no clear benefit of using suction over a water seal after lung surgery. However, some trials suggested that suction might help a collapsed lung heal faster, potentially shortening the hospital stay. Overall, both methods seem promising, but their effectiveness can vary depending on the individual case. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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 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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12271783/

Management of Primary Spontaneous Pneumothorax in the ... All patients treated initially with small-bore chest tube suction were admitted. If suction failed to resolve the pneumothorax in any pathway, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06688734

Study Details | NCT06688734 | Suction Versus Water Seal ... 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 ...

3. isrctn.com isrctn.com/ISRCTNISRCTN18017504

A trial of suction for the early resolution of a collapsed lung In terms of benefits, those randomly assigned to suction may resolve their pneumothorax more quickly and hence a shorter hospital stay. When the study is ...

4. jtd.amegroups.org jtd.amegroups.org/article/view/91863/html

Chest drainage outcomes by water seal versus low suction on ... The water seal method may improve air leak and chest drainage durations compared with the low suction pressure on digital drainage system (DDS).

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2788397

Comprehensive Review of Chest Tube Management This review will provide the nonexpert clinician a comprehensive understanding of the types of chest tubes, indications for their effective use, and key ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK594490/

Chapter 6 Manage Chest Tube Drainage Systems - NCBI - NIH This chapter will review the principles of intrathoracic pressure, the indications for chest tubes, and the safe management of patients with chest tube ...

7. psnet.ahrq.gov psnet.ahrq.gov/web-mm/chest-tube-complications

Chest Tube Complications | PSNet Common complications of chest tube placement are malpositioning and empyema; more unusual complications include organ rupture and problems arising after removal ...