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

NCT ID: NCT03639974

Last Updated: 2019-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-08-23

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.

Detailed Description

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. Methods:This is a randomized clinical trial, with patients in postoperative cardiac surgery. On the first day of postoperative, the patients will be randomized into three groups: 1 group that will receive positive expiratory pressure with blow-bottle device associated with conventional physiotherapy; 2- group that will receive positive expiratory pressure in the airways with valve unidirectional therapy associated with conventional physiotherapy; 3- group that will only receive conventional physiotherapy. The intervention of the positive expiratory pressure with blow-bottle device group will consist of exercise with a blow-bottle device of 10 cm high; the positive expiratory pressure in the airways group, exercise with unidirectional positive expiratory pressure valve (10cmH2O). Both the groups will perform three sets of 10 repetitions per day, by the third day of PO. The third group will receive conventional physiotherapy of intensive care unit. The outcomes evaluated will be: pulmonary function (primary), respiratory muscle strength, pulmonary complications, radiological changes and length of stay (at the Intensive CareUnit - ICU - and hospital). Assessment of pulmonary function, muscle strength and radiological changes will be performed in the preoperative period, prior to the interventions and on the third postoperative day, immediately prior to discharge of cardiac intensive care unit. Pulmonary complications and ICU length of stay will be recorded after discharge from intensive care unit cardiac. The length of hospital stay was recorded after hospital discharge.

Conditions

Thoracic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PEP in a blow-bottle device

Blow-bottle device of 10cmH2O.

Group Type: ACTIVE_COMPARATOR

PEP in a blow-bottle device

Intervention Type: 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.

EPAP Positive airway expiratory pressure

EPAP with pressure of 10 cmH2O.

Group Type: ACTIVE_COMPARATOR

EPAP

Intervention Type: 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.

conventional physiotherapy

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

Group Type: SHAM_COMPARATOR

conventional physiotherapy

Intervention Type: 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.

Interventions

PEP in a blow-bottle device

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.

Intervention Type: OTHER

EPAP

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.

Intervention Type: OTHER

conventional physiotherapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

pulmonary edema

thoracic aortic aneurysm

In order to perform the respiratory muscle strength test, patients may not present the following contraindications:

acute myocardial infarction

recent unstable angina

severe and uncontrolled systemic arterial hypertension

aortic aneurysm

pneumothorax

pleurocutaneous or pulmonary fistulas

surgery or recent trauma to the upper airways, chest or abdomen

abdominal hernia

acute middle ear problems

glaucoma or retinal detachment

hydrocephalus

meningocele

neurological processes that favor the choking of tonsils

general state of physical or mental impairment that impedes the patient's collaboration.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)

UNKNOWN

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graciele Sbruzzi, doctor

Role: PRINCIPAL_INVESTIGATOR

HCPA

Locations

HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33233946 (View on PubMed)

Other Identifiers

17-0460

Identifier Type: -

Identifier Source: org_study_id