Effectiveness of Reanimator Muller in Patients With Chest Tube

Mechanical Ventilation Complication Clinical Trial

Official title:

Effectiveness of Reanimator Muller in Patients With Chest Tube

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02472041
• Other study ID #: 20300313.9.0000.5404
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 21, 2015
• Last updated: June 10, 2015
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: University of Campinas, Brazil
• Contact: Ana Paula R Dos Anjos, mestranda
• Phone: 35 92015986
• Email: pauladosanjos[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with old more 18 years untill 65 years

• Patients undergoing thoracic drainage

• That does not include in any exclusion criteria

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• 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®).
• 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.

Locations

Country	Name	City	State
Brazil	Hospital da Clínicas de campinas	Campinas	Sao Paulo
Brazil	Hospital santa Casa de Passos	Passos	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (12)

Catterall WA, Striessnig J. Receptor sites for Ca2+ channel antagonists. Trends Pharmacol Sci. 1992 Jun;13(6):256-62. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Müller AP, Olandoski M, Macedo R, Costantini C, Guarita-Souza LC. [Comparative study between intermittent (Müller Reanimator) and continuous positive airway pressure in the postoperative period of coronary artery bypass grafting]. Arq Bras Cardiol. 2006 Mar;86(3):232-9. Epub 2006 Mar 30. Portuguese. — View Citation

Pasquina P, Tramèr MR, Granier JM, Walder B. Respiratory physiotherapy to prevent pulmonary complications after abdominal surgery: a systematic review. Chest. 2006 Dec;130(6):1887-99. Review. — View Citation

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

Rahman NM, Chapman SJ, Davies RJ. Pleural effusion: a structured approach to care. Br Med Bull. 2005 Mar 14;72:31-47. Print 2004. Review. — View Citation

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. — View Citation

Woodrow P. Intrapleural chest drainage. Nurs Stand. 2013 Jun 5-11;27(40):49-56; quiz 58. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain	by visual analogue scale of pain (VAS) was used to determine the degree of soreness daily during the hospitalization period and pre chest drainage and after the intervention.	30 days	No
Other	Hospitalization stay	the number of days in the hospital after chest drainage to discharge should be recorded for each patient. All patients were followed during hospitalization.	30 days	Yes
Other	Time length chest drain	The length of the chest drain was checked until hospital discharge. The drain removal criterion was filed by the medical team of the hospital thoracic surgery. Debt drain in ml was collected by nursing professionals who were blinded study.	30 days	Yes
Other	dyspnea	It was determined by the Borg scale, in two stages, before and after intervention in both groups.	30 days	No
Primary	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).	before the intervention (pre) and after drain removal the tube (pos) for 30 days	Yes
Secondary	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.	30 days	Yes