Effectiveness of Reanimator Muller in Patients With Chest Tube

June 10, 2015 updated by: Ana Paula Ragonete dos Anjos, University of Campinas, Brazil
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Passos, Minas Gerais, Brazil, 37900512
        • Recruiting
        • Hospital santa Casa de Passos
        • Contact:
        • Principal Investigator:
          • Ana Paula Dos Anjos, mestranda
        • Sub-Investigator:
          • Luciana Castilho, doutora
        • Sub-Investigator:
          • Luiz Martins, doutor
        • Sub-Investigator:
          • Ivaneide P B Lemos, mestre
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13083-888
        • Not yet recruiting
        • Hospital da Clínicas de campinas
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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®).
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
before the intervention (pre) and after drain removal the tube (pos) for 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saturation Oxygen
Time Frame: 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.
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 30 days
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
Hospitalization stay
Time Frame: 30 days
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
Time length chest drain
Time Frame: 30 days
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
dyspnea
Time Frame: 30 days
It was determined by the Borg scale, in two stages, before and after intervention in both groups.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Investigators

  • Principal Investigator: Ana Paula R Dos Anjos, mestranda, University of Campinas, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20300313.9.0000.5404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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