Effects of Non-invasive Ventilation in Patients Undergoing Heart Surgery

NCT05966337 | Unknown

• 2 other identifiers: ERAECR1202365600722.1.0000.5187
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled clinical trial is to compare effects of non-invasive ventilation with different modalities (notably CPAP and BIPAP) in patients undergoing heart surgery. The main question\[s\] it aims to answer are:

• Which NIV ventilation mode is most effective in cardiac surgery patients?
• Is there a big difference between conventional physiotherapy treatment and the use of NIV in these patients? Participants will be submited in the intervention will initially take place in the specific ward that receives patients in the postoperative period of cardiac surgery. Participants will be recruited after the patient is hospitalized the day before the surgery, during which time he will undergo a preoperative evaluation based on the study criteria. On that first day, the evaluation will consist of anamnesis and physical examination, focusing on the history of cardiac disorders, followed by measurements inherent to the protocol. Manovacuometry, chest X-ray, quality of life questionnaire, walk test and spirometry. The evaluation can be carried out in two stages, if there are other demands for the patient during his hospitalization. Researchers will compare three groups: 1 - cpap group - CPAP + usual physical therapy care, 2 - Bipap group - BIPAP + usual physical therapy care and 3 - Control - usual physical therapy care), in the 1:1 allocation ratio and superiority. to see if the effects of non-invasive ventilation with different modalities in patients undergoing cardiac surgery demonstrates some superior way in clinical practice. The observed outcomes will be: evaluation between NIV modalities, spirometry, lung capacity and vital signs. Secondary outcomes included are degree of satisfaction with the global perception of change scale, and MIF - functional independence measure and blood gas parameters.

Conditions

Cardiac Surgical Procedures; Continuous Positive Airway Pressure; BIPAP Biphasic Intermittent Positive Airway Pressure

Outcome Measures

Primary Outcomes (3)

• Pulmonary function

  All participants will undergo an evaluation by a CONTEC model spirometer (SPB80b, CHINA) to verify lung volumes and capacities. At least three tests will be performed, with a variation of less than 5% and the highest value obtained in one of the tests will be compared with the predicted values of pulmonary function parameters for the Brazilian population. FEV1 and FVC will be assessed. The predicted values will be calculated using the reference values (PEREIRA et al., 2007).

  Day 1 and day 5

• Length of hospital stay

  Absolute number of days of hospitalization up to 2 weeks after the date of randomization.

  The length of hospital stay will be assessed and reported as the number of days from admission to discharge, measured up to 2 weeks after the date of randomization.

• Presence of lung complications

  assessment of the occurrence or absence of any complications related to the lungs during the hospitalization period.cause, whichever occurs first, measured up to 2 weeks

  From the date of randomization to the date of the first documented progression or the date of death from any cause, whichever occurs first, measured up to 2 weeks after the date of hospital discharge.

Secondary Outcomes (9)

• Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version

  Day 1 and Day 5

• Funcional capacity

  Day 1 and Day 5

• The global perception of change scale

  Day 1 and Day 5

• The functional independence measure (MIF)

  Day 1 and Day 5

• pO2 (partial pressure of oxygen)

  Days 1 and 2.

Other Outcomes (8)

• Duration of Cardiopulmonary Bypass

  Day 1

• Type of Surgery

  Day 1

• Personal History

  Day 1

Study Arms (3)

Control group 1 (usual care)

ACTIVE COMPARATOR

Patients undergo physiotherapy treatment twice daily, transitioning from the ICU to the ward. The treatment plan spans several days, starting on the first postoperative day after ICU discharge. In the ICU, Day 1 includes diaphragmatic breathing exercises, coughing stimulus, upper limb exercises (shoulder flexion/extension, abduction), and lower limb exercises (thigh flexion, dorsiflexion/plantarflexion). Day 2 involves diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, cycling for 3 minutes, and respiratory device exercises. Upon moving to the ward on Day 3, patients perform diaphragmatic breathing, coughing stimulus, upper limb exercises, lower limb exercises, and a 5-minute walk. Day 4 focuses on diaphragmatic breathing, coughing stimulus, and a 10-minute walk. Finally, on Day 5, patients engage in diaphragmatic breathing, coughing stimulus, and a 15-minute walk.

Procedure: Usual care in phisicaltherapy

Intervention group 2 (CPAP)

EXPERIMENTAL

They will be submitted to the same care as the control group, adding NIV with nasal CPAP 10cmH2O for 1 hour using device and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward. The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported.

Procedure: CPAP; Procedure: Usual care in phisicaltherapy

Intervention group 2 (BIPAP):

EXPERIMENTAL

They will undergo the same care as the control group, adding NIV with nasal BIPAP with IPAP of 13cmH2O and EPAP 8 cmH2O for 1 hour, using equipment and brand approved by ANVISA, during the 5 days of hospitalization, both in the ICU and in the ward . The frequency of the sessions will be two (2) per day, in the morning and in the afternoon. Flexibility of time for carrying out the procedure is also planned, since in a hospital environment the patient can often undergo exams, other behaviors that may make it difficult to apply the protocol at the initially scheduled time. After the fifth day, the patient will be reassessed with the same instruments reported.

Procedure: BIPAP; Procedure: Usual care in phisicaltherapy

Interventions

CPAP PROCEDURE

Use of non-invasive ventilation in patients in group 2 with CPAP.

Intervention group 2 (CPAP)

BIPAP PROCEDURE

Use of non-invasive ventilation in patients in group 3 with BIPAP.

Intervention group 2 (BIPAP):

Usual care in phisicaltherapy PROCEDURE

Patients undergoing usual physiotherapy treatment, consisting of a kinesiotherapy protocol

Control group 1 (usual care); Intervention group 2 (BIPAP):; Intervention group 2 (CPAP)

Eligibility Criteria

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

You may qualify if:

• aged over 18 years
• stable from the hemodynamic point of view (controlled blood pressure, normocardic
• conscious and oriented and cooperative4
• without medical restrictions for carrying out the treatment

You may not qualify if:

• Presence of uncontrolled cardiac arrhythmias (Examples: total atrioventricular block, type 2 2nd degree atrioventricular block, atrial fibrillation, sustained ventricular tachycardia)
• previous neuromuscular disease
• labyrinthitis and some orthopedic/skeletal muscle restriction.
• Unstable angina, stage 3 SAH (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at rest), HR \> 120 bpm at rest, systemic arterial hypotension with clinical repercussions (SBP ≤ 90 mmHg and/or DBP ≤ 60 mmHg),(),
• aortic dissection.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead
• Universidade Estadual da Paraiba: collaborator

Study Sites (1)

Hospital João XXIII

Campina Grande, Paraíba, 58108-620, Brazil

RECRUITING

Related Publications (15)

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• Carvalho VO, Guimaraes GV, Carrara D, Bacal F, Bocchi EA. Validation of the Portuguese version of the Minnesota Living with Heart Failure Questionnaire. Arq Bras Cardiol. 2009 Jul;93(1):39-44. doi: 10.1590/s0066-782x2009000700008. English, Portuguese, Spanish.

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  PMID: 30725604 BACKGROUND

• Araujo ER, Bezerra Nogueira ID, E Silva Barbosa PE, Silva Nogueira PAM. Effects of Non-Invasive Ventilation with different modalities in patients undergoing heart surgery: Protocol for a randomized controlled clinical trial. PLoS One. 2024 Jun 18;19(6):e0304569. doi: 10.1371/journal.pone.0304569. eCollection 2024.

  PMID: 38889140 DERIVED

Central Study Contacts

Eder R Araújo, doctoral

CONTACT

+5583988998813; eder.rodrigues.araujo@gmail.com

Patrícia Nogueira, doctor

CONTACT

+5584988777454; idpa02@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head professor of physiotherapy course and pós-graduate course.

Model Details: Pacients will be divided into 3 groups (CPAP group - CPAP + usual physical therapy care, BiPAP group - BiPAP + usual physical therapy care, and Control group - usual physical therapy care) in a 1:1 allocation ratio. Control group will receive the usual physiotherapy treatment, as kinesiotherapy protocol. Treatment will be administered twice a day, starting in the ICU and progressing to the ward. In the CPAP group, nasal CPAP at 10cmH2O will be administered for 1 hour, twice a day, using an approved device. In BiPAP group, nasal BiPAP with IPAP of 13cmH2O and EPAP of 8cmH2O will be administered for 1 hour, twice a day, using an approved device. The NIV sessions will be conducted during the 5 days of hospitalization, both in the ICU and the ward. After the fifth day, patients in intervention groups will undergo reassessment using the same assessment instruments as before.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 28, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)