Clinical trial NCT05966337: Effects of Non-invasive Ventilation in Patients Undergoing Heart Surgery
Official title: Effects of Non-invasive Ventilation With Different Modalities in Patients Undergoing Heart Surgery: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Surgical Procedures
Continuous Positive Airway Pressure
BIPAP Biphasic Intermittent Positive Airway Pressure
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
Collaborators: name: Universidade Estadual da Paraiba
First posted: 2023-07-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The study protocol was conducted following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded. The study will be submitted to the ethics committee of the State University of Paraíba (UEPB) and carried out in accordance with the Declaration of Helsinki. All participants must provide written informed consent prior to participation, and the study will be registered on the CLINICALTRIALS platform. All participants must provide written informed consent prior to participation. Participants will be divided into three 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 and superiority.

The project will be carried out at Hospital João XXIII in the city of Campina Grande, Paraíba, Brazil. It is a private hospital affiliated with the SUS network, a reference in cardiology and especially in cardiac surgery for a good part of the state and surrounding states. It presents in its weekly program an average of 8 cardiac surgeries. The evaluation and intervention will take place in the ICU and ward.

Post-randomization exclusion criteria: In case of undertaking any treatment in the hospital environment that contraindicates participation in the study (pacemaker implantation, pneumothorax requiring chest drainage, for example), death or other decompensations not related to the research and return to the ICU .

Criteria for non-adherence to the intervention: Patient who does not perform 3 or more sessions in a row, who withdrew from participating in the study and who has some cardiac arrhythmia (atrial fibrillation, bradycardia) for two sessions even after medication used to contain and pause for rest.

Non-retention criteria: Patient who does not perform one of the reassessments. Professional eligibility criteria: Hospital staff physiotherapists and physiotherapy students with previous training in the research protocol.

Procedures for Conducting the Research The purpose of this project is to carry out a randomized clinical trial and verify the effectiveness of NIV compared to conventional physiotherapy in terms of the rate of pulmonary complications in patients undergoing cardiac surgery in a chosen hospital in the city of Campina Grande, Paraíba.

Thus, there will be a partnership with the Núcleo de Tecnologia Estratégicas em Saúde (NUTES) of the State University of Paraíba (UEPB) through the biomedical computing laboratory for the development of research aimed at the remote monitoring of health data through smartwatches and other devices that comply with international standardization norms for interoperability between health technologies. NUTES already collaborates with UFRN in several scientific and technological cooperation researches, so that the co-supervisor of the project, Prof Paulo Eduardo Barbosa made the strategic partnership possible, according to the attached document. NUTES' participation in this project will take place through the feasibility of remote monitoring technology via Smartwatch and the introduction of data collected on a specific platform.

For a better understanding and operationalization of the research, it was divided into 5 phases.

1. st Phase: Documentary Survey and Consent At first, there was initial contact with the aforementioned hospital institution for consent to the research. At the same time, a documentary and systematic study on the subject was instituted, in order to base the research and identify possible indices and/or parameters that would add to the research in order to make it viable and absolutely realistic.
2. nd Phase: Search and profile of NIV and Smartwatch devices Non-invasive ventilation (NIV) will be performed both in the ICU environment and in the ward for the intervention group. A BIPAP will be made available and a CPAP for the respective groups. The interface chosen will be the nasal mask, aiming at greater patient comfort. Thus, we will choose properly calibrated NIV devices on the market that provide better adaptation to patients.

   All the main information about users can be entered into the platform, such as gender, age, other illnesses, use of medication, and some special situations that can be verified in practice, in addition to information that may come from the monitoring carried out by the smartwatch on patients in the moment of data collection during NIV application. Thus, data from the patient's medical record will also be used. A large volume of data can be entered into the platform and used to generate a profile of cardiac patients selected for the survey. The smartwatch used will be from the Garmin brand and available for capturing Sao2 and VO2.

   The main functionalities of the Dashboard comprise the visualization of the data of the surgical patients submitted to NIV in the initial screen in a computer, being able to apply filters according to the interest of the researcher.
3. rd Phase: Technical Study and applied tests

   This project is interested in three major aspects: the use of non-invasive ventilation in heart patients undergoing cardiac surgery; the automation of data collection using the smartwatch, making it practical, simple, accessible technology in order to become a predictor of safe discharge for these patients; finally, a survey of a large volume of data (verified in the analysis profile of the patients) that can generate subsidies for carrying out research and contribute to the increase of studies in the area of cardiopulmonary physiotherapy on technological bases.
4. th Phase: Pilot Study - Practice After that, the surgeries will begin and the collection will consist of 6 patients, thus defining the beginning of the pilot study. Upon being notified of the weekly surgical schedule, the researcher in charge will randomize the patients. This register will contain the complete identification of the patient, type of surgery to which he will be submitted and the pathology.

   Thus, as the patients leave the surgical center and go to the ICU, they will follow the protocol so that the treatment due to the group to which the patient is allocated on the day after the surgery begins.

   It should be noted that the pilot study should only be started after approval by CEP.

   After completion of the pilot study, there will be an evaluation of the entire protocol so that possible flaws can be corrected before definitive collection.
5. th Phase: Data collection It will consist of collecting data from patients in the post-randomization intervention and allocation of patients to a group, following the procedures of the protocol.

Eligibility criteria: Inclusion Criteria: Patients undergoing cardiac surgery

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pulmonary function
timeFrame: Day 1 and day 5
measure: Length of hospital stay
timeFrame: 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.
measure: Presence of lung complications
timeFrame: 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:
measure: Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version
timeFrame: Day 1 and Day 5
measure: Funcional capacity
timeFrame: Day 1 and Day 5
measure: The global perception of change scale
timeFrame: Day 1 and Day 5
measure: The functional independence measure (MIF)
timeFrame: Day 1 and Day 5
measure: pO2 (partial pressure of oxygen)
timeFrame: Days 1 and 2.
measure: pCO2 (partial pressure of carbon dioxide)
timeFrame: Days 1 and 2.
measure: HCO3 (bicarbonate)
timeFrame: Days 1 and 2.
measure: Arterial Oxygen Saturation (SaO2)
timeFrame: Days 1 and 2.
measure: Base Excess (BE)
timeFrame: Days 1 and 2.
Other outcomes:
measure: Duration of Cardiopulmonary Bypass
timeFrame: Day 1
measure: Type of Surgery
timeFrame: Day 1
measure: Personal History
timeFrame: Day 1
measure: Preoperative Ejection Fraction
timeFrame: Day 1
measure: Previous Respiratory Complications
timeFrame: Day 1
measure: Body Mass Index (BMI)
timeFrame: Day 1
measure: Gender
timeFrame: Day 1
measure: Age
timeFrame: Day 1
Locations:
city: Campina Grande
country: Brazil
facility: Hospital João XXIII
state: PB
Study officials:
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