Lung CancerCTS-POPNCT04369118
Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection
A study testing Conventional follow-up and Conventional follow-up+chest wall restriction belt in people with Lung Cancer, run by University Hospital, Grenoble at 3 sites in France.
Trial summary
The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Conventional follow-up and Conventional follow-up+chest wall restriction belt
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesFrance
- Study dates
- 18 Nov 2020to 29 Feb 2024
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with segmentectomy or lobectomy for lung cancer or lung cancer suspicious,
- Surgical approach : video-assisted thoracic surgery (VATS) or thoracotomy,
- Patients affiliated to social security or similarly regime,
- Patients who gave their consent to participate in the study.
Who cannot join
- Patients with outcomes of the pulmonary function test at the preoperative assessment : forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) > 45% predicted post-operative values and VO2max (maximal oxygen consumption) between 10 and 12 ml/kg/min,
- Patients with a waist size > 120 cm
- Patients with medical treatment for chronic pain (neuropathic pain,…)
- Patients with tuberculosis or other pulmonary infectious pathology proven (aspergillosis, lung abscess, actinomycosis,…),
- Patients carrying a resistant germs or extended-spectrum beta-lactamase (ESBL),
- Paraplegic patients
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- Patients with a diagnosed, progressive and/or uncontrolled neurological disease
- Patients with a progressive psychosis or a serious psychotic history (hospitalization)
- Patients who are in exclusion period of another interventional study
- Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Trial locations and contacts
3 sites in 1 country.
France3 sites
Assistance Publique Hôpitaux de Paris, Hôpital Avicenne
Bobigny, 93000
Hôpital Louis Pradel
Bron, 69500
CHU Grenoble Alpes
Grenoble, 38043
About this study
Official title: Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection. A Multicenter, Prospective, Controlled, Randomized Study With Stratification on the Surgical Approach, Open With a Blind Analysis
The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer.
The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.
Read the detailed description
The present study is the first evaluation of the efficacy of a selective chest wall restriction belt.
The efficacy will be estimate on forced expiratory volume in one second (FEV1) at D3 by comparing 2 groups: a control group of patients with conventional follow-up and an experimental group of patients with conventional follow-up and a daily wear of the selective chest wall restriction belt after surgery.
- Conditions
- Lung Cancer
- Being tested
- Conventional follow-up, Conventional follow-up+chest wall restriction belt
- Keywords
- chest wall restriction, usability, lung surgery, medical device, pain, cough, expectoration
- Medical subject headings
- Lung Neoplasms, Pain, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional follow-upProcedure or surgery
Patients in this group benefit from conventional post-operative follow-up
Conventional follow-up+chest wall restriction beltDevice
Patients in this group benefit from conventional post-operative follow-up. The patient wear the selective chest wall restriction belt from Day 2 (after surgery) until he ceases to need it.
| Study group | Role | What they receive |
|---|---|---|
| Conventional follow-up+chest wall restriction belt | Experimental | Patients in this group benefit from conventional post-operative follow-up and wear the selective chest wall restriction belt in parallel. Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1 Receives: Procedure: Conventional follow-up; Device: Conventional follow-up+chest wall restriction belt |
| conventional postoperative follow-up | Active comparator | Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1 Receives: Procedure: Conventional follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of forced expiratory volume in one second (FEV1) between the two groups.
Comparisons of forced expiratory volume in one second (FEV1) between the two groups at Day 3. The value of FEV1 is standardized with pre-operative one.
Measured: 3 days
Secondary outcomes (12)
Comparisons of pulmonary function test between the two groups
Comparisons of pulmonary function test ( forced expiratory volume in one second (FEV1), Forced vital capacity (FVC)) between the two groups. They are expressed as Liters. Before surgery, all days from Day 2 to the patient's exit from hospital (max Day 6) and at the follow-up visit at Month 1. Each value is standardized with pre-operative one.
Measured: 1 month
Comparisons of Peak expiratory flow at cough between the two groups
Comparisons of Peak expiratory flow at cough (PEF) between the two groups. It is expressed as Liters per second. Before surgery, all days from Day 2 to Day 6 and at the follow-up visit at Month 1. Each value is standardized with pre-operative one.
Measured: 1 month
Pain evaluation at rest and during cough: ENS scale
The patient pain is evaluated using the ENS (Echelle Numérique Standard; standard digital scale, score between 0 to 10) for the two groups. The pain is evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
Measured: 1 month
Qualification of cough
The cough is classified with this scale : 0-dry cough; 1-productive cough without expectoration; 2-productive cough with expectoration; 3-productive cough with important and/or difficult expectoration. It's qualified for the two groups all days from Day 2 to the patient's exit from hospital.
Measured: 10 days
Characterization of analgesic treatment.
The analgesic drugs are characterized by their class, dose and number of dose taken in the two groups. These elements are evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
Measured: 1 month
Identification of using aerosol therapy, antibiotic therapy and loco-regional anaesthesia
Use of aerosol therapy (yes/no) and class of drugs. Use of antibiotic therapy (yes/no), type of drugs and expected duration of treatment. Use of loco-regional anaesthesia (yes/no), modality of administration and type of drugs. These elements are evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
Measured: 1 month
Number and classification of post-surgery complications
Number and classification of post-surgery complications.For the two groups from Day 1 to the follow-up visit at Month 1.
Measured: 1 month
The length of hospital stay
The length of hospital stay in days for the two groups.
Measured: 10 days
Quantification of the quality of life evaluated with the EQ-5D-5L questionnaire
The EQ-5D is a generic preference-based measure that indirectly measures the utility for health that generates an index-based summary score based upon societal preference weights. The EQ-5D-5L consists of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale (VAS) for health status. Each item has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The VAS ranges from 0 (worst health status) and 100 (best health status). Comparison between the two groups preoperatively, at the patient's exit from hospital, at Day 15 during the phone follow-up and at the follow-up visit at Month 1.
Measured: 1 month
Consumption of hospital care
Comparions of the number of the consumption of hospital care (medical acts and consultations, rehospitalization) between the two groups from Day 1 to the follow-up visit at Month 1.
Measured: 1 month
Evaluation of medical device usability for patient
Only for the medical device's group.
- Qualitative questionnaire specifically created about efficacy and acceptability of the medical device at the patient 's exit from hospital. This questionnaire uses Likert scale from 0 to 10 to evaluate each use step of the medical device, closed-ended questions and open questions for comments. A descriptive analysis will done with the answers
- Closed-ended questions will be asked in a questionnaire specifically created about acceptability and use of the medical device. A descriptive analysis will done with the answers and will be asked during the weekly phone follow-up.
Measured: 1 month
Evaluation of medical device usability for caregivers
Only for the medical device's group. This questionnaire uses Likert scales from 0 to 10 to evaluate each use step ofthe medical device, closed-ended questions and open questions fr comments. It will be asked at the end of the clinical study at each caregiver.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start18 Nov 2020
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369118
- Sponsor's protocol ID
- 38RC19.102
- Acronym
- CTS-POP
- Status last verified
- May 2024
- First submitted
- 10 Mar 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection. A Multicenter, Prospective, Controlled, Randomized Study With Stratification on the Surgical Approach, Open With a Blind Analysis
- ClinicalTrials.gov ID
- NCT04369118
- Acronym / sponsor ID
- CTS-POP / 38RC19.102
- Conditions
- Lung Cancer
- Keywords
- chest wall restriction, usability, lung surgery, medical device, pain, cough, expectoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 30 Apr 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 objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer.
The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.
Detailed description
The present study is the first evaluation of the efficacy of a selective chest wall restriction belt.
The efficacy will be estimate on forced expiratory volume in one second (FEV1) at D3 by comparing 2 groups: a control group of patients with conventional follow-up and an experimental group of patients with conventional follow-up and a daily wear of the selective chest wall restriction belt after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional follow-up+chest wall restriction belt | Experimental | Procedure: Conventional follow-up, Device: Conventional follow-up+chest wall restriction beltPatients in this group benefit from conventional post-operative follow-up and wear the selective chest wall restriction belt in parallel. Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1 |
| conventional postoperative follow-up | Active comparator | Procedure: Conventional follow-upPatients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with segmentectomy or lobectomy for lung cancer or lung cancer suspicious,
- Surgical approach : video-assisted thoracic surgery (VATS) or thoracotomy,
- Patients affiliated to social security or similarly regime,
- Patients who gave their consent to participate in the study.
Key exclusion criteria (10 listed)
- Patients with outcomes of the pulmonary function test at the preoperative assessment : forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) > 45% predicted post-operative values and VO2max (maximal oxygen consumption) between 10 and 12 ml/kg/min,
- Patients with a waist size > 120 cm
- Patients with medical treatment for chronic pain (neuropathic pain,…)
- Patients with tuberculosis or other pulmonary infectious pathology proven (aspergillosis, lung abscess, actinomycosis,…),
- Patients carrying a resistant germs or extended-spectrum beta-lactamase (ESBL),
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 |
|---|---|---|
| Conventional follow-upPatients in this group benefit from conventional post-operative follow-up | Procedure or surgery | Conventional follow-up+chest wall restriction belt, conventional postoperative follow-up |
| Conventional follow-up+chest wall restriction beltPatients in this group benefit from conventional post-operative follow-up. The patient wear the selective chest wall restriction belt from Day 2 (after surgery) until he ceases to need it. | Device | Conventional follow-up+chest wall restriction belt |
Primary outcome
Comparison of forced expiratory volume in one second (FEV1) between the two groups.
Time frame: 3 days
Comparisons of forced expiratory volume in one second (FEV1) between the two groups at Day 3. The value of FEV1 is standardized with pre-operative one.
12 secondary outcomes
Comparisons of pulmonary function test between the two groups
Time frame: 1 month
Comparisons of Peak expiratory flow at cough between the two groups
Time frame: 1 month
Pain evaluation at rest and during cough: ENS scale
Time frame: 1 month
Qualification of cough
Time frame: 10 days
Characterization of analgesic treatment.
Time frame: 1 month
Identification of using aerosol therapy, antibiotic therapy and loco-regional anaesthesia
Time frame: 1 month
Number and classification of post-surgery complications
Time frame: 1 month
The length of hospital stay
Time frame: 10 days
Quantification of the quality of life evaluated with the EQ-5D-5L questionnaire
Time frame: 1 month
Consumption of hospital care
Time frame: 1 month
Evaluation of medical device usability for patient
Time frame: 1 month
Evaluation of medical device usability for caregivers
Time frame: 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 17 May 2024.
- Informations about CIC-ITLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional follow-up and Conventional follow-up+chest wall restriction belt in people with Lung Cancer, run by University Hospital, Grenoble at 3 sites in France.
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 4 inclusion and 10 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 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. 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?
Comparison of forced expiratory volume in one second (FEV1) between the two groups. (time frame: 3 days). 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 17 May 2024.