Effectiveness of Reanimator Muller in Patients With Chest Tube

NCT ID: NCT02472041

Last Updated: 2015-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Reanimator Group

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

Group Type EXPERIMENTAL

Reanimator group

Intervention Type DEVICE

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®).

Control Group

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.

Group Type EXPERIMENTAL

Control

Intervention Type DEVICE

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.

Interventions

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Reanimator group

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®).

Intervention Type DEVICE

Control

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with old more 18 years untill 65 years
* Patients undergoing thoracic drainage

Exclusion Criteria

* Contraindications breathing equipment use positive pressure

* Patient intolerance
* Phobia
* Hemodynamic instability
* Use of vasopressiva therapy
* Shock (systolic pressure \<90 mmHg)
* Face trauma
* Nausea or vomiting
* Acute myocardial infarction
* Lobectomy
* Lung cancer
* Gastrointestinal surgery
* Pleural fistula.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Ana Paula Ragonete dos Anjos

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Paula R Dos Anjos, mestranda

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

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Hospital santa Casa de Passos

Passos, Minas Gerais, Brazil

Site Status RECRUITING

Hospital da Clínicas de campinas

Campinas, São Paulo, Brazil

Site Status NOT_YET_RECRUITING

Countries

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Brazil

Central Contacts

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Ana Paula R Dos Anjos, mestranda

Role: CONTACT

35 92015986

Luiz C Martins, Doutor

Role: CONTACT

Facility Contacts

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Ivaneide P B Lemos, mestre

Role: primary

35 35227777

Luiz C Martins, doutor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15767562 (View on PubMed)

Hooper 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.

Reference Type BACKGROUND
PMID: 20696692 (View on PubMed)

Porcel JM, Light RW. Diagnostic approach to pleural effusion in adults. Am Fam Physician. 2006 Apr 1;73(7):1211-20.

Reference Type BACKGROUND
PMID: 16623208 (View on PubMed)

Woodrow 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.

Reference Type BACKGROUND
PMID: 23909181 (View on PubMed)

Kao 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.

Reference Type BACKGROUND
PMID: 23651575 (View on PubMed)

Westerdahl 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.

Reference Type BACKGROUND
PMID: 11474953 (View on PubMed)

Pasquina 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.

Reference Type BACKGROUND
PMID: 17167013 (View on PubMed)

Hall 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.

Reference Type BACKGROUND
PMID: 2009796 (View on PubMed)

Muller 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.

Reference Type BACKGROUND
PMID: 16612452 (View on PubMed)

Ludwig 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.

Reference Type BACKGROUND
PMID: 21357311 (View on PubMed)

Catterall 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.

Reference Type BACKGROUND
PMID: 1321525 (View on PubMed)

Holanda 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.

Reference Type BACKGROUND
PMID: 20363847 (View on PubMed)

Other Identifiers

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20300313.9.0000.5404

Identifier Type: -

Identifier Source: org_study_id

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