NCT02472041

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 15, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

May 21, 2015

Last Update Submit

June 10, 2015

Conditions

Mechanical Ventilation Complication

Keywords

chest drain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Saturation Oxygen

    30 days

Other Outcomes (4)

  • Pain

    30 days

  • Hospitalization stay

    30 days

  • Time length chest drain

    30 days

  • +1 more other outcomes

Study Arms (2)

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

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.

Device: Control

Interventions

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®).

Reanimator Group
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.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital santa Casa de Passos

Passos, Minas Gerais, 37900512, Brazil

RECRUITING

Hospital da Clínicas de campinas

Campinas, São Paulo, 13083-888, Brazil

NOT YET RECRUITING

Related Publications (12)

  • 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.

    PMID: 15767562BACKGROUND

  • 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.

    PMID: 20696692BACKGROUND

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

    PMID: 16623208BACKGROUND

  • 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.

    PMID: 23909181BACKGROUND

  • 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.

    PMID: 23651575BACKGROUND

  • 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.

    PMID: 11474953BACKGROUND

  • 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.

    PMID: 17167013BACKGROUND

  • 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.

    PMID: 2009796BACKGROUND

  • 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.

    PMID: 16612452BACKGROUND

  • 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.

    PMID: 21357311BACKGROUND

  • 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.

    PMID: 1321525BACKGROUND

  • 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.

    PMID: 20363847BACKGROUND

Study Officials

  • Ana Paula R Dos Anjos, mestranda

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Paula R Dos Anjos, mestranda

CONTACT

35 92015986pauladosanjos@yahoo.com.br

Luiz C Martins, Doutor

CONTACT

19luizpneumo@uol.com.br

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 21, 2015

First Posted

June 15, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

June 15, 2015

Record last verified: 2015-05

Locations

BR(2)