Positive Expiratory Pressure With Blow-bottle Device Versus EPAP After Postoperative Cardiac Surgery

NCT03639974 | Completed

• 1 other identifier: 17-0460
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients through a randomized clinical trial. Methods: The study was approved by the Research Ethics Committee of the Hospital de Clínicas of Porto Alegre (CAEE: 70213617.6.0000.5327). Patients undergoing cardiac surgery were randomized into three groups: positive expiratory pressure with blow-bottle device associated with conventional physiotherapy (G1), positive expiratory pressure in the airways with unidirectional valve associated with conventional physiotherapy (G2), and the third group only the conventional physiotherapy of HCPA cardiac intensive care unit (G3). Initially, an evaluation was performed through spirometry, manovacuometry, radiological changes in the preoperative period, prior to the interventions (immediate postoperative) and on the third postoperative day, immediately prior to cardiac intensive care unit discharge. Pulmonary complications were assessed on the third postoperative day, and length of stay (at the Intensive Care Unit and hospital) were recorded untill discharge.

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (3)

• Pulmonary function - forced vital capacity

  Pulmonary function through spirometry. Spirometry allows to measure forced vital capacity. It's the air volume expired, quickly, after an inspiration deep maximum.

  three days

• Pulmonary function - forced expiratory volume in the first second

  Pulmonary function through spirometry, that allows to measure forced expiratory volume in the first second. It's the maximum expired volume at the first second of an maximum expiration .

  three days

• Pulmonary function - the ratio: forced expiratory volume in the first second / forced vital capacity

  Pulmonary function through spirometry, obtained through forced maneuver (forced vital capacity) and forced expiratory volume in the first second - represents the maximum expired volume at the first second of an maximum expiration.

  three days

Secondary Outcomes (15)

• Respiratory muscle strength - maximum expiratory pressure

  three days

• Respiratory muscle strength - maximal inspiratory pressure

  three days

• Pulmonary complications - atelectasis

  three days

• Pulmonary complications - pleural effusion

  three days

• Pulmonary complications - pneumothorax

  three days

Study Arms (3)

PEP in a blow-bottle device

ACTIVE COMPARATOR

Blow-bottle device of 10cmH2O.

Other: PEP in a blow-bottle device

EPAP Positive airway expiratory pressure

ACTIVE COMPARATOR

EPAP with pressure of 10 cmH2O.

Other: EPAP

conventional physiotherapy

SHAM COMPARATOR

Ventilatory exercises, bronchial hygiene techniques, exercises for upper and lower limbs (previous motor condition) stretching, orientation and walking.

Other: conventional physiotherapy

Interventions

PEP in a blow-bottle device OTHER

A 500-milliliter enteral nutrition vial will be used, which will contain a hole in the side, where two silicone tubes of 20 centimeters long will be inserted together with tape on the bottleneck of the vial. To perform the exercise, the vial will be filled with water leaving a water column of 10 cm high. Deep inspirations will be requested at a volume greater than the tidal volume and less than the total lung capacity that can be performed via nasal or oral, then with the mouth connected to the extensors, the patient will exhale slowly, avoiding to totally empty the lungs. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA.

PEP in a blow-bottle device

EPAP OTHER

The Vital Signs ® EPAP kit will be used. Exercises will be performed in the bed, and as soon as the patient is released by the medical team to leave the bed, they can be performed in the sitting position or in orthostasis. For performing the exercise, the EPAP mask will be connected to the face of the patient. The expiratory pressure will be adjusted to 10cmH2O. Deep inspirations will be requested at a volume greater than the tidal volume and below the total lung capacity, then the patient will exhale slowly. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA, as described in the conventional physiotherapy group.

EPAP Positive airway expiratory pressure

conventional physiotherapy OTHER

Conventional physical therapy consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resisted lower limb exercises; stretching, cough and walking guidelines. Initially the exercises will be performed in the bed, as soon as this is withdrawn and the patient is released by the medical team to leave the bed, the progression of the exercises to be performed in the sitting position, orthostasis, and ambulation is performed, this usually occurs on the 2nd postoperative day, after the removal of the mediastinal drain . Under supervision of the physiotherapist, the protocol will be performed twice daily, two sets of ten repetitions.

conventional physiotherapy

Eligibility Criteria

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

You may qualify if:

• Elective cardiovascular surgery of:
• coronary artery bypass graft surgery alone
• coronary artery bypass graft surgery combined with aortic valve surgery
• coronary artery bypass graft surgery combined with bicuspid valve surgery
• coronary artery bypass graft surgery combined with tricuspid valve surgery
• Aortic valve surgery
• Bicuspid valve surgery
• Tricuspid valve surgery
• All on spontaneous ventilation or with supplemental oxygen support.

You may not qualify if:

• Patients with hemodynamic instability (heart rate\> 120bpm, clinically important hypotension - vasopressor dose ≥ 0.1mcg / kg / min)
• Cardiac arrhythmia
• Heart transplantation
• Angina at rest and/or minor efforts
• Mechanical ventilation for more than 24 hours
• Re-hospitalized patients with decompensated heart failure
• Noninvasive mechanical ventilation
• Non-collaborative and with cognitive inability to understand the procedures
• Reintubated patients
• Re-operated patients
• In order to perform the pulmonary function test, patients may not present the following contraindications:
• hemoptysis
• recent angina
• retinal detachment
• hypertensive crisis

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS): collaborator

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90.035-903, Brazil

Location

Related Publications (1)

• Pieczkoski SM, de Oliveira AL, Haeffner MP, Azambuja ACM, Sbruzzi G. Positive expiratory pressure in postoperative cardiac patients in intensive care: A randomized controlled trial. Clin Rehabil. 2021 May;35(5):681-691. doi: 10.1177/0269215520972701. Epub 2020 Nov 24.

  PMID: 33233946 DERIVED

Study Officials

• Graciele Sbruzzi, doctor

  HCPA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double blind: allocation concealment and outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized clinical trial that will be performed according to the CONSORT Statement (Consolidated Standards of ReportingTrials).

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 21, 2018
• Study Start: August 1, 2018
• Primary Completion: May 20, 2019
• Study Completion: August 23, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)