Water Seal vs. Suction for Collapsed Lung (SEAL IT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
No Placebo Group
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.
12345Is 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.
678910How 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.
678911Eligibility 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 am under the care of the trauma surgery team.
I have had a collapsed lung treated with a chest tube.
Exclusion Criteria
I am under 18 years old.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Initial Water SealExperimental Treatment1 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 SuctionExperimental Treatment1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
References
[Incidence of ventilator-associated pneumonia in patients using open-suction systems and closed-suction systems: a prospective study -- preliminary data]. [2019]This a randomized clinical trial in which 20 patients were prospectively evaluated for the incidence of ventilator-associated pneumonia (VAP), of whom 12 received endotracheal suctioning by an open-suction method and 8 by a closed-suction method. Differences in the incidence of VAP was not significantly different (p = 0.4) between closed and open suctioning. Differences in Acute Physiology and Chronic Health Evaluation II, duration of entubation, and the use of steroids were all not significant. All patients in the study used H2 antagonist and a nasogastric tube. Proceeding with the study will involve a sample increase with a possible change in the results.
Can nurses safely assess the need for endotracheal suction in short-term ventilated patients, instead of using routine techniques? [2019]Most literature describes endotracheal suction as a hazardous procedure associated with numerous complications and proposes that it should only be performed as necessary to minimize these complications. Other authors suggest endotracheal suction only after assessment predisposes patients to a number of different complications. This article describes a controlled study to compare and contrast the differences in endotracheal suction outcomes in patients who received ritualized 2 hourly suctioning and those who received it following assessment. A group of qualified nurses in an Intensive Care Unit were taught auscultation skills to assess a patient's needs for suctioning and all the nurses received educational training regarding endotracheal suctioning. Short-term ventilated patients were allocated to receive endotracheal suctioning either when the need for it was determined by assessment only or routinely, using a standardized suctioning technique. The results demonstrated a clear increase in nurses' knowledge regarding endotracheal suctioning. The assessed group of patients demonstrated significantly better outcomes and less complications than the controlled group in relation to changes in peak airway pressures, heart rate and mean arterial pressure pre- and post-endotracheal suctioning, and the amount of secretions obtained on suctioning. Although only preliminary, these results do provide support for the view that endotracheal suction only in response to assessment is better practice for short-term ventilated patients.
Evidence-based suction management in accident and emergency: a vital component of airway care. [2019]Effective airway management aims to establish and maintain a patent airway to ensure adequate alveolar ventilation and patient survival. Suction therapy must be regarded as a vital component of airway care, with all staff who are required to perform this procedure being aware of the principles of safe, effective suctioning. This paper provides an outline of the types of suction catheters available for use in the emergency care setting, and describes the safe procedures to be followed for both endotracheal and oro-pharyngeal suctioning. Potential complications are discussed other headings of respiratory, cardiovascular, immunological and traumatic, all of which are relevant to safe patient care whatever the setting, and all of which should be recognizable by any staff undertaking this procedure. The final section looks at the ways in which some of the complications can be minimized or detected by relating some of the more important theoretical points discussed throughout the paper to the practical situation. Suction therapy is not without risk for the patient and, although the frequency of suction therapy is far less in Accident and Emergency (A & E) than in the Intensive Care Unit, the potential dangers remain the same. In order to minimize some of the dangers and reduce confusion amongst staff, this paper concludes with a recommendation for a degree of standardization in suction catheter use.
Endotracheal suction in intubated critically ill adult patients undergoing mechanical ventilation: a systematic review. [2019]identify and analyze in the literature the evidence of randomized controlled trials on care related to the suctioning of endotracheal secretions in intubated, critically ill adult patients undergoing mechanical ventilation.
As-needed endotracheal suctioning protocol vs a routine endotracheal suctioning in Pediatric Intensive Care Unit: A randomized controlled trial. [2022]To compare two endotracheal suctioning protocols according to morbidity, days of mechanical ventilation, length of stay in the Pediatric Intensive Care Unit (PICU), incidence of Ventilator-Associated Pneumonia (VAP) and mortality.
Suction vs water seal after pulmonary resection: a randomized prospective study. [2022]To evaluate whether suction or water seal is superior in the management of chest tubes after pulmonary resection.
Management of chest tubes after pulmonary resection: a systematic review and meta-analysis. [2022]We performed a systematic review and meta-analysis to determine the effect of suction with water seal, compared with water seal alone, applied to intra pleural chest tubes on the duration of air leaks in patients undergoing pulmonary surgery.
Randomized study of algorithms for discontinuing tube thoracostomy drainage. [2006]The optimal method for removal of chest tubes has not been determined and opinion remains divided. The purpose of this study was to determine the difference between two algorithms for the removal of chest tubes: one with continuous negative intrathoracic pressure (suction group) and the other with a trial of water seal (water-seal group).
Initial chest tube management after pulmonary resection. [2022]Tube thoracostomy management with suction or water seal after anatomical pulmonary resection remains somewhat controversial. Initial chest tube management may influence the duration of pleural fluid drainage, duration of tube thoracostomy, and/or hospital length of stay following pulmonary resection. We hypothesized that initial chest tube management with water seal decreases time for chest tube removal and decreases time of hospital stay. A retrospective chart review was performed on 109 consecutive patients who underwent lobectomy or segmentectomy in Western Pennsylvania Hospital between December 1999 and December 2003. Comparison was made between chest tube management of water seal or suction in patients with and without air leak. Of the 109 patients, 78 (72%) had no air leak at the completion of surgery, and 31 (28%) had air leak. In the group without air leak (n = 78), water seal was used in 32 (41%) patients and suction in 46 (59%). In patients placed to water seal initially after surgery (n = 32), removal of chest tubes was on postoperative day (POD) 3.19 +/- 0.24 and hospital discharge was on POD 5.13 +/- 0.61. In patients placed to suction initially (n = 46), chest tubes were removed on POD 4.52 +/- 0.40. Hospital discharge was on POD 6.74 +/- 0.5. Both duration of chest tube (P
Removal of chest tubes in children without water seal after elective thoracic procedures: a randomized prospective study. [2019]Chest tubes are often placed in children after elective thoracic surgical procedures. Depending on surgeon preference, tubes can be pulled directly from suction or after a trial of water seal. Removal of the tube without water seal potentially allows earlier removal, decreased postoperative pain, and earlier discharge from the hospital. No randomized, prospective study has been performed to compare the two methods to determine whether omission of the water seal period is safe after elective thoracic surgery in children.
Comparison of water seal and suction after pulmonary lobectomy: a prospective, randomized trial. [2022]The objective of the present study was to assess whether placing chest tubes on water seal after pulmonary lobectomy reduced the duration of air leak compared with suction.