Effectiveness of Reanimator Muller in Patients With Chest Tube

Phase 2

• Conditions: Mechanical Ventilation Complication
• Interventions: Device: Reanimator group; Device: Control

• Registration Number: NCT02472041
• Lead Sponsor: University of Campinas, Brazil

Brief 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.

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 Timeline

• Study Start: 2014-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-21
• Study First Submitted QC: 2015-06-10
• Last Update Submitted: 2015-06-10
• Study First Posted: 2015-06-15
• Last Update Posted: 2015-06-15
• Primary Completion: 2015-09
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reanimator Group	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
Control Group	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 (Table 1). Guidelines to the active, progressive and early mobilization.

Primary Outcome Measures

Name	Time	Method
Change Respiratory function	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).

Secondary Outcome Measures

Name	Time	Method
Saturation Oxygen	30 days	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.

Trial Locations

Locations (2)

Hospital santa Casa de Passos; 🇧🇷 Passos, Minas Gerais, Brazil

Hospital da Clínicas de campinas; 🇧🇷 Campinas, Sao Paulo, Brazil