Positive Airway Pressure on Pleural Effusion After Drainage

NCT02246946 | Completed

• 1 other identifier: UNICID14
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the addition of intermittent positive airway pressure breathing (specific lung expansion technique) to conventional chest physiotherapy chest drainage is effective to accelerate the reabsorption of pleural effusion and consequently decrease the duration of chest tube drainage and respiratory system impairment. These effects would decrease hospital stay lengths and the incidence of pulmonary complications.

Conditions

Pleural Effusion

Keywords

pleural effusion; chest tube; respiratory therapy; intermittent positive-pressure breathing; lung function; pulmonary complications

Outcome Measures

Primary Outcomes (1)

• Duration of chest tube drainage

  The criteria for the removal the chest drain will an output of transudative fluid over 24h ≤ 200 ml and full lung expansion on chest radiography

  All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage

Secondary Outcomes (4)

• Spirometry

  On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol

• Peripheral Oxygen Saturation

  On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol

• Pulmonary complications

  All patients will be followed for the duration of hospital stay, an expected average of 10 days

• Length of hospital stay

  All patients will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (3)

Positive Airway Pressure group

EXPERIMENTAL

The patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and walking for 100 meters (i.e., the same treatment that will be administered to the Conventional Chest Physiotherapy group). Additionally, this group will receive positive airway pressure breathing with 15 mmHg by a device via a rubber facial mask for 30 minutes in a sitting position.

Device: Positive Airway Pressure

Conventional Chest Physiotherapy group

ACTIVE COMPARATOR

In the sitting position, the patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and positive airway pressure breathing with 4 mmHg via a rubber facial mask for 5 minutes in a sitting position. These patients will also walk for 100 meters. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the equipment in the room and mark the patient's skin.

Other: Conventional Chest Physiotherapy

Control group

PLACEBO COMPARATOR

The patients allocated to this group will receive positive airway pressure breathing with 4 mmHg (without therapeutic value) via a rubber facial mask for 30 minutes in a sitting position. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the complete kit of equipment in the room.

Procedure: Control group

Interventions

Positive Airway Pressure DEVICE

To this group, Intermittent Positive Airway Pressure Breathing with 15 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide

Positive Airway Pressure group

Conventional Chest Physiotherapy OTHER

To this group, routine physiotherapy exercises will be conducted plus Intermittent Positive Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide

Conventional Chest Physiotherapy group

Control group PROCEDURE

to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• presence of pleural effusion
• have undergone chest drain for fewer than 24 hours

You may not qualify if:

• contraindication to the use of non-invasive equipment that generates positive airway pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion, hemodynamic instability requiring vasopressor therapy, systolic blood pressure \< 90 mmHg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting, upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours, pneumothorax or bullous emphysema)

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital das Clínicas Dr. Alberto Lima

Macapá, Amapá, 68900073, Brazil

Location

Related Publications (2)

• Dos Santos EDC, da Silva JS, de Assis Filho MTT, Vidal MB, Monte MC, Lunardi AC. Adding positive airway pressure to mobilisation and respiratory techniques hastens pleural drainage: a randomised trial. J Physiother. 2020 Jan;66(1):19-26. doi: 10.1016/j.jphys.2019.11.006. Epub 2019 Dec 13.

  PMID: 31843426 DERIVED

• da Conceicao Dos Santos E, Lunardi AC. Efficacy of the addition of positive airway pressure to conventional chest physiotherapy in resolution of pleural effusion after drainage: protocol for a randomised controlled trial. J Physiother. 2015 Apr;61(2):93. doi: 10.1016/j.jphys.2014.11.016. Epub 2015 Mar 3.

  PMID: 25744852 DERIVED

MeSH Terms

Conditions

Pleural Effusion

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Adriana C Lunardi, PhD

  Universidade Cidade de Sao Paulo

  STUDY DIRECTOR

• Elinaldo C Santos, MSc

  Hospital das Clínicas Dr. Alberto Lima

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor on Master's and Doctoral Programs in Physical Therapy of Universidade Cidade de São Paulo

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 23, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

BR (1)