Chest Injury TraumaNCT04673084
Under Water Seal Versus Negative Pleural Suction in Chest Trauma Patients
An observational study of Chest Injury Trauma, run by Assiut University.
Trial summary
:The investigators aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chest Injury Trauma
- What is being tested?
- negative pleural suction
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: : patients who presented to Trauma Department, Assiut University Hospital and who meet the listed inclusion will be eligible for the study. The charts will be reviewed and eligible patients will be filtered.
Who may be able to join
- • 1-Pneumothorax after penetrating or blunt chest trauma
- 2-Hemothorax after penetrating or blunt chest trauma
- 3-Hemopneumothorax after penetrating or blunt chest trauma 4-All patients of all ages and genders are included
Who cannot join
- 1-Anyperson associating with body trauma outside chest.
- 2-Invasive mechanical ventilation
- 3-Emergent Surgery (thoracoscopy, open thoracotomy)
- 4-Chronic pulmonary diseases (COPD, CRPD)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chest Tube Drainage With Under Water Seal Versus Addition Of Negative Pleural Suction In Chest Trauma Patients
:The investigators aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.
Read the detailed description
Traumas are the leading cause of death in the first four decades of life and are mostly caused by traffic accidents. Thoracic traumas might lead to severe consequences, even though less than 50% of them required a surgical revision. Thoracic traumas can be divided in blunt or penetrating, according to the presence of open wound in the chest. Blunt traumas are the most frequent type of chest trauma with or without rib fractures that might be associated with haemothorax, pneumothorax or haemopneumothorax that are the most typical lesions or laceration.
Pleural chest tubes are used to reestablish negative intrathoracic pressure after disruption of the pleural space. Chest tube positioning is considered necessary in case of a pleural disruption with pneumothorax; intrapleural bleeding causing haemothorax; or in case of pneumo-haemothorax .
The management of pleural chest tubes with primarily under water seal or added suction is the subject of debate, and the benefits of one versus the other in regards to duration of air leak, amount of time the chest tube is in place, length of hospital stay and incidence of complications are unclear.
All of the previous made us interesting to examine the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group, the investigators think that power of suction will give the patient better results with less complications and excellent immediate relief with good quality of life, rapid return to normal life .
- Conditions
- Chest Injury Trauma
- Being tested
- negative pleural suction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
negative pleural suctionDevice
by comparing the effect of water seal alone of chest tube in one groups of trauma patients and the effect of both water seal and suction in other group
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease duration of hospital stay.
We can measure this by:
Amount and duration of airleak in chest tube.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Apr 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest Injury TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yahia Abd almonem Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673084
- Sponsor's protocol ID
- Negative pleural suction
- Status last verified
- Mar 2021
- First submitted
- 18 Oct 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall Goal: We aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of water seal alone of chest tube in one groups of trauma patients and the effect of both water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.
Publications
Muslim M, Bilal A, Salim M, Khan MA, Baseer A, Ahmed M. Tube thorocostomy: management and outcome in patients with penetrating chest trauma. J Ayub Med Coll Abbottabad. 2008 Oct-Dec;20(4):108-11.
PubMed 19999219
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Tube Drainage With Under Water Seal Versus Addition Of Negative Pleural Suction In Chest Trauma Patients
- ClinicalTrials.gov ID
- NCT04673084
- Acronym / sponsor ID
- Negative pleural suction
- Conditions
- Chest Injury Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
:The investigators aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.
Detailed description
Traumas are the leading cause of death in the first four decades of life and are mostly caused by traffic accidents. Thoracic traumas might lead to severe consequences, even though less than 50% of them required a surgical revision. Thoracic traumas can be divided in blunt or penetrating, according to the presence of open wound in the chest. Blunt traumas are the most frequent type of chest trauma with or without rib fractures that might be associated with haemothorax, pneumothorax or haemopneumothorax that are the most typical lesions or laceration.
Pleural chest tubes are used to reestablish negative intrathoracic pressure after disruption of the pleural space. Chest tube positioning is considered necessary in case of a pleural disruption with pneumothorax; intrapleural bleeding causing haemothorax; or in case of pneumo-haemothorax .
The management of pleural chest tubes with primarily under water seal or added suction is the subject of debate, and the benefits of one versus the other in regards to duration of air leak, amount of time the chest tube is in place, length of hospital stay and incidence of complications are unclear.
All of the previous made us interesting to examine the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group, the investigators think that power of suction will give the patient better results with less complications and excellent immediate relief with good quality of life, rapid return to normal life .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- : patients who presented to Trauma Department, Assiut University Hospital and who meet the listed inclusion will be eligible for the study. The charts will be reviewed and eligible patients will be filtered.
Key inclusion criteria (3 listed)
- • 1-Pneumothorax after penetrating or blunt chest trauma
Key exclusion criteria (4 listed)
- 1-Anyperson associating with body trauma outside chest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| negative pleural suctionby comparing the effect of water seal alone of chest tube in one groups of trauma patients and the effect of both water seal and suction in other group | Device | – |
Primary outcome
Decrease duration of hospital stay.
Time frame: baseline
We can measure this by: Amount and duration of airleak in chest tube.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Background: PubMed 19999219Muslim M, Bilal A, Salim M, Khan MA, Baseer A, Ahmed M. Tube thorocostomy: management and outcome in patients with penetrating chest trauma. J Ayub Med Coll Abbottabad. 2008 Oct-Dec;20(4):108-11.
- Individual participant dataSharing planned: No. Overall Goal: We aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of water seal alone of chest tube in one groups of trauma patients and the effect of both water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Injury Trauma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yahia Alassal, 493474 (0201066580715, yayaalassal94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease duration of hospital stay. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04673084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.