Mechanical Ventilation ComplicationPhase 2/3NCT02472041
Effectiveness of Reanimator Muller in Patients With Chest Tube
A Phase 2/3 study testing Reanimator group in people with Mechanical Ventilation Complication, run by University of Campinas, Brazil at 2 sites in Brazil.
Trial summary
This study evaluates the comparison of two of re-expansion pulmonary physiotherapy in patients with chest tube. The study group received intermittent positive pressure intervention and the control group received incentive spirometry intervention associated with manual operation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Reanimator group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2014to Oct 2015
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with old more 18 years untill 65 years
- Patients undergoing thoracic drainage
- That does not include in any exclusion criteria
Who cannot join
- Contraindications breathing equipment use positive pressure
- Patient intolerance
- Phobia
- Hemodynamic instability
- Use of vasopressiva therapy
- Shock (systolic pressure <90 mmHg)
Show all 13Show fewer
- Face trauma
- Nausea or vomiting
- Acute myocardial infarction
- Lobectomy
- Lung cancer
- Gastrointestinal surgery
- Pleural fistula.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Not yet recruiting
Hospital da Clínicas de campinas
Campinas, São Paulo, 13083-888
Luiz C Martins, doutor, 19, luizpneumo@uol.com.br
- Recruiting
Hospital santa Casa de Passos
Passos, Minas Gerais, 37900512
Ivaneide P B Lemos, mestre, 35 35227777, iveneidelemos@scpassos.org.br
Ana Paula Dos Anjos, mestranda
About this study
This study evaluates the comparison of two of re-expansion pulmonary physiotherapy in patients with chest tube. The study group received intermittent positive pressure intervention and the control group received incentive spirometry intervention associated with manual operation.
Read the detailed description
All the re-expansion methods increase lung volume increasing gradient of transpulmonary pressure (PL) representing the difference alveolar pressure and pleural pressure. Spontaneous deep breath increases the PL by reducing pleural pressure (active breathing exercises, breathing supporters and manual operation).
Muller resuscitator consists of a pneumatic valve feature designed to operate with medical oxygen. It is used intermittently or continuously for pulmonary re-expansion, with lower load imposed work, and increase the efficiency of gas exchange by improving volumes, lung capacity and breathing pattern, and reverse atelectasis.
However, studies show the paucity of data in the literature regarding the Muller Resuscitator in different forms and respiratory rehabilitation protocols. In addition, studies show lack of standardization of methods and resources used in respiratory therapy in patients with chest tube.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Reanimator group, Control
- Keywords
- chest drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reanimator groupDevice
Resuscitator of Muller Group (intermittent positive pressure): Patients allocated to this group received intermittent positive pressure breathing (resuscitator Muller, Engemed, Brazil), adjusting the positive pressure around 1.5 kgf / cm2, which corresponds to 15 20 cm / H2O, positive pressure was applied through a face mask (Respironics®).
ControlDevice
Control Group: In position Fowler 45, patients assigned to this group was administered as treatment lung expansion exercises using the incentive inspiratory flow (Respiron, NCS, Mexico) and concomitantly blocking contralateral to the drain maneuvers were performed, compression / decompression associated with the incentive spirometry (Respiron) consisting of 4 sets of 10 active patient breaths with an interval of two minutes between sets. Since the load of the respiratory stimulator will be zero throughout treatment. Guidelines to the active, progressive and early mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Reanimator Group | Experimental | Reanimator of Muller Group (intermittent positive pressure): Patients allocated to this group received intermittent positive pressure breathing (resuscitator Muller, Engemed, Brazil), adjusting the positive pressure around 1.5 kgf / cm2, which corresponds to 15 20 cm / H2O, positive pressure was applied through a face mask (Respironics®), which was connected in a circuit extending along the Muller Resuscitator equipment applied continuously for four series 10 of the patient breaths active and with an interval of two minutes between them in Fowler 45 position Receives: Device: Reanimator group |
| Control Group | Experimental | Control Group: In position Fowler 45, patients assigned to this group was administered as treatment lung expansion exercises using the incentive inspiratory flow (Respiron, NCS, Mexico) and concomitantly blocking contralateral to the drain maneuvers were performed, compression / decompression associated with the incentive spirometry (Respiron) consisting of 4 sets of 10 active patient breaths with an interval of two minutes between sets. Since the load of the respiratory stimulator will be zero throughout treatment (Table 1). Guidelines to the active, progressive and early mobilization. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Respiratory function
Ventilometry was evaluated in two stages: 1) before the intervention, 2) on the day of drain removal or discharge. The spirometer application is according to implement stable and acceptable criteria. TOBIN The measures of lung volumes forão performed with the spirometer (FERRARIS MK8 Wright ®) coupled to a nozzle. The patient was instructed to breathe quietly in the apparatus for a minute to read the minute volume (VM). During this period, it is checked the number of breaths, i.e., respiratory rate (RR) for calculating the tidal volume (VT) given by VC = VM / FR (ml).
Measured: before the intervention (pre) and after drain removal the tube (pos) for 30 days
Secondary outcomes (1)
Saturation Oxygen
Oxygen saturation was assessed in two stages: 1) before the first intervention of the day 2) after daily intervention protocol until hospital discharge or removal of the chest tube. Patients were evaluated with breathing in ambient air (without supplemental oxygen) after 10 minutes of the procedure. The researcher used a pulse oximeter portable.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Ragonete dos Anjos, University of Campinas, Brazil
- Investigators
- Ana Paula R Dos Anjos, mestranda, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472041
- Sponsor's protocol ID
- 20300313.9.0000.5404
- Status last verified
- May 2015
- First submitted
- 21 May 2015
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rahman NM, Chapman SJ, Davies RJ. Pleural effusion: a structured approach to care. Br Med Bull. 2005 Mar 14;72:31-47. doi: 10.1093/bmb/ldh040. Print 2004.
PubMed 15767562Hooper C, Lee YC, Maskell N; BTS Pleural Guideline Group. Investigation of a unilateral pleural effusion in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii4-17. doi: 10.1136/thx.2010.136978. No abstract available.
PubMed 20696692Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
PubMed 16623208Woodrow P. Intrapleural chest drainage. Nurs Stand. 2013 Jun 5-11;27(40):49-56; quiz 58. doi: 10.7748/ns2013.06.27.40.49.e7373.
PubMed 23909181Kao JH, Kao HK, Chen YW, Yu WK, Pan SW, Wang JH, Lien TC, Ho LI, Kou YR. Impact and predictors of prolonged chest tube duration in mechanically ventilated patients with acquired pneumothorax. Respir Care. 2013 Dec;58(12):2093-100. doi: 10.4187/respcare.02273. Epub 2013 May 7.
PubMed 23651575Westerdahl E, Lindmark B, Almgren SO, Tenling A. Chest physiotherapy after coronary artery bypass graft surgery--a comparison of three different deep breathing techniques. J Rehabil Med. 2001 Mar;33(2):79-84. doi: 10.1080/165019701750098920.
PubMed 11474953Pasquina P, Tramer MR, Granier JM, Walder B. Respiratory physiotherapy to prevent pulmonary complications after abdominal surgery: a systematic review. Chest. 2006 Dec;130(6):1887-99. doi: 10.1378/chest.130.6.1887.
PubMed 17167013Hall JC, Tarala RA, Hall JL, Mander J. A multivariate analysis of the risk of pulmonary complications after laparotomy. Chest. 1991 Apr;99(4):923-7. doi: 10.1378/chest.99.4.923.
PubMed 2009796Muller AP, Olandoski M, Macedo R, Costantini C, Guarita-Souza LC. [Comparative study between intermittent (Muller Reanimator) and continuous positive airway pressure in the postoperative period of coronary artery bypass grafting]. Arq Bras Cardiol. 2006 Mar;86(3):232-9. doi: 10.1590/s0066-782x2006000300012. Epub 2006 Mar 30. Portuguese.
PubMed 16612452Ludwig C, Angenendt S, Martins R, Mayer V, Stoelben E. Intermittent positive-pressure breathing after lung surgery. Asian Cardiovasc Thorac Ann. 2011 Feb;19(1):10-3. doi: 10.1177/0218492310394664.
PubMed 21357311Catterall WA, Striessnig J. Receptor sites for Ca2+ channel antagonists. Trends Pharmacol Sci. 1992 Jun;13(6):256-62. doi: 10.1016/0165-6147(92)90079-l.
PubMed 1321525Holanda MA, Fortaleza SC, Alves-de-Almeida M, Winkeler GF, Reis RC, Felix JH, Lima JW, Pereira ED. Continuous positive airway pressure effects on regional lung aeration in patients with COPD: a high-resolution CT scan study. Chest. 2010 Aug;138(2):305-14. doi: 10.1378/chest.09-2850. Epub 2010 Apr 2.
PubMed 20363847
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Reanimator Muller in Patients With Chest Tube
- ClinicalTrials.gov ID
- NCT02472041
- Acronym / sponsor ID
- 20300313.9.0000.5404
- Conditions
- Mechanical Ventilation Complication
- Keywords
- chest drain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 15 Jun 2015 (estimated)
- 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.
This study evaluates the comparison of two of re-expansion pulmonary physiotherapy in patients with chest tube. The study group received intermittent positive pressure intervention and the control group received incentive spirometry intervention associated with manual operation.
Detailed description
All the re-expansion methods increase lung volume increasing gradient of transpulmonary pressure (PL) representing the difference alveolar pressure and pleural pressure. Spontaneous deep breath increases the PL by reducing pleural pressure (active breathing exercises, breathing supporters and manual operation).
Muller resuscitator consists of a pneumatic valve feature designed to operate with medical oxygen. It is used intermittently or continuously for pulmonary re-expansion, with lower load imposed work, and increase the efficiency of gas exchange by improving volumes, lung capacity and breathing pattern, and reverse atelectasis.
However, studies show the paucity of data in the literature regarding the Muller Resuscitator in different forms and respiratory rehabilitation protocols. In addition, studies show lack of standardization of methods and resources used in respiratory therapy in patients with chest tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reanimator Group | Experimental | Device: Reanimator groupReanimator of Muller Group (intermittent positive pressure): Patients allocated to this group received intermittent positive pressure breathing (resuscitator Muller, Engemed, Brazil), adjusting the positive pressure around 1.5 kgf / cm2, which corresponds to 15 20 cm / H2O, positive pressure was applied through a face mask (Respironics®), which was connected in a circuit extending along the Muller Resuscitator equipment applied continuously for four series 10 of the patient breaths active and with an interval of two minutes between them in Fowler 45 position |
| Control Group | Experimental | Device: ControlControl Group: In position Fowler 45, patients assigned to this group was administered as treatment lung expansion exercises using the incentive inspiratory flow (Respiron, NCS, Mexico) and concomitantly blocking contralateral to the drain maneuvers were performed, compression / decompression associated with the incentive spirometry (Respiron) consisting of 4 sets of 10 active patient breaths with an interval of two minutes between sets. Since the load of the respiratory stimulator will be zero throughout treatment (Table 1). Guidelines to the active, progressive and early mobilization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with old more 18 years untill 65 years
- Patients undergoing thoracic drainage
- That does not include in any exclusion criteria
Key exclusion criteria (13 listed)
- Contraindications breathing equipment use positive pressure
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 |
|---|---|---|
| Reanimator groupResuscitator of Muller Group (intermittent positive pressure): Patients allocated to this group received intermittent positive pressure breathing (resuscitator Muller, Engemed, Brazil), adjusting the positive pressure around 1.5 kgf / cm2, which corresponds to 15 20 cm / H2O, positive pressure was applied through a face mask (Respironics®). | Device | Reanimator Group |
| ControlControl Group: In position Fowler 45, patients assigned to this group was administered as treatment lung expansion exercises using the incentive inspiratory flow (Respiron, NCS, Mexico) and concomitantly blocking contralateral to the drain maneuvers were performed, compression / decompression associated with the incentive spirometry (Respiron) consisting of 4 sets of 10 active patient breaths with an interval of two minutes between sets. Since the load of the respiratory stimulator will be zero throughout treatment. Guidelines to the active, progressive and early mobilization. | Device | Control Group |
Primary outcome
Change Respiratory function
Time frame: before the intervention (pre) and after drain removal the tube (pos) for 30 days
Ventilometry was evaluated in two stages: 1) before the intervention, 2) on the day of drain removal or discharge. The spirometer application is according to implement stable and acceptable criteria. TOBIN The measures of lung volumes forão performed with the spirometer (FERRARIS MK8 Wright ®) coupled to a nozzle. The patient was instructed to breathe quietly in the apparatus for a minute to read the minute volume (VM). During this period, it is checked the number of breaths, i.e., respiratory rate (RR) for calculating the tidal volume (VT) given by VC = VM / FR (ml).
1 secondary outcome
Saturation Oxygen
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Background: PubMed 15767562Rahman NM, Chapman SJ, Davies RJ. Pleural effusion: a structured approach to care. Br Med Bull. 2005 Mar 14;72:31-47. doi: 10.1093/bmb/ldh040. Print 2004.
- Background: PubMed 20696692Hooper C, Lee YC, Maskell N; BTS Pleural Guideline Group. Investigation of a unilateral pleural effusion in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii4-17. doi: 10.1136/thx.2010.136978. No abstract available.
- Background: PubMed 16623208Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.
- Background: PubMed 23909181Woodrow P. Intrapleural chest drainage. Nurs Stand. 2013 Jun 5-11;27(40):49-56; quiz 58. doi: 10.7748/ns2013.06.27.40.49.e7373.
- Background: PubMed 23651575Kao JH, Kao HK, Chen YW, Yu WK, Pan SW, Wang JH, Lien TC, Ho LI, Kou YR. Impact and predictors of prolonged chest tube duration in mechanically ventilated patients with acquired pneumothorax. Respir Care. 2013 Dec;58(12):2093-100. doi: 10.4187/respcare.02273. Epub 2013 May 7.
- Background: PubMed 11474953Westerdahl E, Lindmark B, Almgren SO, Tenling A. Chest physiotherapy after coronary artery bypass graft surgery--a comparison of three different deep breathing techniques. J Rehabil Med. 2001 Mar;33(2):79-84. doi: 10.1080/165019701750098920.
- Background: PubMed 17167013Pasquina P, Tramer MR, Granier JM, Walder B. Respiratory physiotherapy to prevent pulmonary complications after abdominal surgery: a systematic review. Chest. 2006 Dec;130(6):1887-99. doi: 10.1378/chest.130.6.1887.
- Background: PubMed 2009796Hall JC, Tarala RA, Hall JL, Mander J. A multivariate analysis of the risk of pulmonary complications after laparotomy. Chest. 1991 Apr;99(4):923-7. doi: 10.1378/chest.99.4.923.
- Background: PubMed 16612452Muller AP, Olandoski M, Macedo R, Costantini C, Guarita-Souza LC. [Comparative study between intermittent (Muller Reanimator) and continuous positive airway pressure in the postoperative period of coronary artery bypass grafting]. Arq Bras Cardiol. 2006 Mar;86(3):232-9. doi: 10.1590/s0066-782x2006000300012. Epub 2006 Mar 30. Portuguese.
- Background: PubMed 21357311Ludwig C, Angenendt S, Martins R, Mayer V, Stoelben E. Intermittent positive-pressure breathing after lung surgery. Asian Cardiovasc Thorac Ann. 2011 Feb;19(1):10-3. doi: 10.1177/0218492310394664.
- Background: PubMed 1321525Catterall WA, Striessnig J. Receptor sites for Ca2+ channel antagonists. Trends Pharmacol Sci. 1992 Jun;13(6):256-62. doi: 10.1016/0165-6147(92)90079-l.
- Background: PubMed 20363847Holanda MA, Fortaleza SC, Alves-de-Almeida M, Winkeler GF, Reis RC, Felix JH, Lima JW, Pereira ED. Continuous positive airway pressure effects on regional lung aeration in patients with COPD: a high-resolution CT scan study. Chest. 2010 Aug;138(2):305-14. doi: 10.1378/chest.09-2850. Epub 2010 Apr 2.
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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.
Ana Paula R Dos Anjos, mestranda principal investigator
University of Campinas, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Reanimator group in people with Mechanical Ventilation Complication, run by University of Campinas, Brazil at 2 sites in Brazil.
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 13 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ana Paula R Dos Anjos, mestranda (35 92015986, pauladosanjos@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Respiratory function (time frame: before the intervention (pre) and after drain removal the tube (pos) for 30 days). 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 NCT02472041, which also lists 12 linked publications.
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 15 Jun 2015.