PneumothoraxNCT05243316
Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology
A study testing Clamping and Non Clampling in people with Pneumothorax and Chest Tube, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial summary
Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pneumothorax, Chest Tube, Pleural Diseases
- What is being tested?
- Clamping and Non Clampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteMexico
- Study dates
- 22 Dec 2021to 15 Apr 2023
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 16 years and more.
- Patients hospitalized in the National Institute of Respiratory Diseases.
- Patients who had a chest tube placement during their stay at the hospital, by any cause.
Who cannot join
- Patients who refuse to sign the informed consent and who refuse to participate in the study.
- Patients who die before randomization.
- Patients who gets chest tube removal before being randomized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases
Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping.
The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.
Read the detailed description
Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal).
Incidence of 24hour pneumothorax after chest tube removal will be recorded.
- Conditions
- Pneumothorax, Chest Tube, Pleural Diseases
- Being tested
- Clamping, Non Clampling
- Keywords
- Chest tube, Pneumothorax, Pleural Diseases
- Medical subject headings
- Pneumothorax, Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClampingProcedure or surgery
There will be a randomized selection of patients who will have a clamping of the chest tube 6 hours prior to chest tube removal.
Non ClamplingProcedure or surgery
There will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clamping of the chest tube | Active comparator | Patients with 6hour clamping prior to removal Receives: Procedure: Clamping |
| Patients without clamping of the chest tube | Sham comparator | Patients will have chest tube removed immediately Receives: Procedure: Non Clampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumothorax after chest tube removal with chest tube clamping
Cases of pneumothorax after chest tube removal despite clamping
Measured: After 24 hours of procedure
Incidence of pneumothorax after chest tube removal without chest tube clamping
Cases of pneumothorax after chest tube removal despite clamping
Measured: After 24 hours of procedure
Secondary outcomes (1)
Hospital days of stay
Hospital days of stay
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start22 Dec 2021
- Primary completion31 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sebastian Rodriguez, Doctor, Study director, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243316
- Sponsor's protocol ID
- C58-21
- Status last verified
- Feb 2022
- First submitted
- 31 Jan 2022
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Database will be available once the protocol is complete
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases
- ClinicalTrials.gov ID
- NCT05243316
- Acronym / sponsor ID
- C58-21
- Conditions
- Pneumothorax, Chest Tube, Pleural Diseases
- Keywords
- Chest tube, Pneumothorax, Pleural Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 17 Feb 2022 (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.
Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping.
The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.
Detailed description
Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal).
Incidence of 24hour pneumothorax after chest tube removal will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Patients with clamping of the chest tube | Active comparator | Procedure: ClampingPatients with 6hour clamping prior to removal |
| Patients without clamping of the chest tube | Sham comparator | Procedure: Non ClamplingPatients will have chest tube removed immediately |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 16 years and more.
- Patients hospitalized in the National Institute of Respiratory Diseases.
- Patients who had a chest tube placement during their stay at the hospital, by any cause.
Key exclusion criteria (3 listed)
- Patients who refuse to sign the informed consent and who refuse to participate in the study.
- Patients who die before randomization.
- Patients who gets chest tube removal before being randomized.
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 |
|---|---|---|
| ClampingThere will be a randomized selection of patients who will have a clamping of the chest tube 6 hours prior to chest tube removal. | Procedure or surgery | Patients with clamping of the chest tube |
| Non ClamplingThere will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal. | Procedure or surgery | Patients without clamping of the chest tube |
Primary outcome
Incidence of pneumothorax after chest tube removal with chest tube clamping
Time frame: After 24 hours of procedure
Cases of pneumothorax after chest tube removal despite clamping
Incidence of pneumothorax after chest tube removal without chest tube clamping
Time frame: After 24 hours of procedure
Cases of pneumothorax after chest tube removal despite clamping
1 secondary outcome
Hospital days of stay
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Yes. Database will be available once the protocol is complete
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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.
Sebastian Rodriguez, Doctor study director
Instituto Nacional de Enfermedades Respiratorias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamping and Non Clampling in people with Pneumothorax and Chest Tube, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
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 3 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: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pneumothorax after chest tube removal with chest tube clamping (time frame: After 24 hours of procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.