BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients

Study Overview
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Brief Summary
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Effectiveness of BIPAP is evaluated in Type-2 failure but evaluation of effectiveness of CPAP in Type-2 respiratory failure in post cardiac surgery patients was not done. So the objective of this study is to determine the acute effects of BIPAP vs. CPAP with conventional physiotherapy on Hemodynamics and Respiratory parameters in management of Type 2 Respiratory failure in post cardiac surgery patients.

Detailed Description
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Non-invasive ventilation (NIV) refers to the provision of Ventilatory support through the patient's upper airway using a mask or similar device. This technique is distinguished from those which bypass the upper airway with a tracheal tube, laryngeal mask, or tracheotomy and are therefore considered invasive. NIV refers to non-invasive positive pressure ventilation, Continuous positive airway pressure (CPAP) refers to the non-invasive application of positive airway pressure, again using a face or nasal mask rather than in conjunction with invasive techniques. A study on Non-invasive ventilation in postoperative patients was conducted in 2017 in Italy; systematic review was performed on Patients undergoing any of the following procedures, thoracic surgery, lung surgery, abdominal surgery, solid organ transplantation, thoraco-abdominal surgery and bariatric surgery were included. Information on demographics, medical history, preoperative medications, postoperative care Pharmacologic management and laboratory investigation results were obtained from medical charts. Prospective, randomized, case-controlled, pilot study included forty patients, who underwent elective (OPCAB) and were randomized into two groups. group-A (BiPAP) and group-B . All patients received same regimen of medication. Group-B was kept on BiPAP immediately following extubation, while, group-B received conventional physiotherapy only. All hemodynamic and oxygenation parameter were recorded and chest radiographs were done to find out incidence of atelectasis. Patients were followed up to their discharge. Noninvasive Ventilatory support does not facilitate recovery from acute respiratory failure in chronic obstructive pulmonary disease his investigation evaluates, in a prospective, randomized and controlled manner, whether noninvasive ventilatory support (NIVS) with bilevel positive airway pressure (BiPAP) facilitates recovery from acute respiratory failure (ARF) in patients with chronic obstructive pulmonary disease. Effects of Positive Airway Pressure in Patients with Heart Failure and Obstructive Sleep Apnea done at Toronto General Hospital University Health Network and Mount Sinai Hospital Twenty-four patients with a depressed left ventricular ejection fraction (45 percent or less) and obstructive sleep apnea who were receiving optimal medical treatment for heart failure underwent polysomnography. The subjects were then randomly assigned to receive medical therapy either alone (12 patients) or with the addition of continuous positive airway pressure (12 patients) for one month. The assessment protocol was then repeated. Bilevel positive airway pressure on ventricular ectopy in heart failure patients with obstructive sleep apnoea was done at canada in 2015. Following optimisation of medical treatment and cpap.The frequency of vpbs and urinary norepinephrine (noradrenaline) concentrations during total sleep time were determined at baseline and after 1 month

Official Title
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Acute Effects of BIPAP vs CPAP on Hemodynamics and Respiratory Parameters in Management of Type 2 Respiratory Failure Patients

Conditions
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Type 2 Respiratory Failure

Intervention / Treatment
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* Other: BiPAP Group
* Other: CPAP Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 2 respiratory Failure partial pressure of Oxygen(PaO2) of <8 kilopascal(kPa) and pco2 of >6 kpa with a respiratory acidosis pH<7.35 (H+>45nmol/L) guidelines provided by British Thoracic society. Patients with Sleep apnea /acute confusional state (Psychosis) Exclusion Criteria: Person with Surgical Emphysema Pneumothorax Medically unstable (hypotensive shock, uncontrolled cardiac ischemia, or arrhythmia Person with Bulla's disease Severe bronchospasm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiPAP Group<br>Bilevel Positive Airway Pressure | Other: BiPAP Group<br>* BIPAP - 1hr after every 6hrs for 3 days/week Conventional physiotherapy Treatment (Percussion, vibration, shaking) Modified postural drainage Incentive spirometer Blow bottle/Tissue blowing/Positive Expiratory Pressure(PEP) device<br>|
| Experimental: CPAP Group<br>Continuous Positive Airway Pressure | Other: CPAP Group<br>* CPAP - 1hr after every 6hrs for 3 days/week Conventional physiotherapy Treatment (Percussion, vibration, shaking) Modified postural drainage Incentive spirometer Blow bottle/Tissue blowing/PEP device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood gas (ABG) parameter like potential of hydrogen (PH) | Above parameter was measured by serial ABG analysis. Its normal reference range is 7.35-7.45. baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline | 3rd Day | 
| Arterial blood gas parameter like bicarbonate(HCO3). | Above parameter was measured by serial ABG analysis. Its normal reference range is 22-28 nmol/L. Baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline | 3rd Day | 
| Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2) | Above parameter was measured by serial ABG analysis. Its normal reference range is 35-45 mmHg. Baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline | 3rd Day | 
| Arterial blood gas parameter like partial pressure of carbon dioxide (PO2) | Above parameter was measured by serial ABG analysis. Its normal reference range is 80-100 mmHg. Baseline reading will be taken at 10 minutes before starting Non invasive ventilation training. Changes from the Baseline | 3rd Day | 
| Heart Rate | Changes from the Baseline, It will be measured through Cardiac Monitor | 3rd Day | 
| Saturation (SPO2) | Changes from the Baseline, It will be measured in percentage through Cardiac Monitor. | 3rd Day | 
| Systolic Blood Pressure (SBP) | Changes from the Baseline, It was measure through sphygmomanometer and Blood pressure is measured in units of millimeters of mercury (mmHg). The readings are always given in pairs, with the upper (systolic) value first, followed by the lower (diastolic) value. | 3rd day | 
| Diastolic Blood Pressure (SBP) | Changes from the Baseline, It was measure through sphygmomanometer and Blood pressure is measured in units of millimeters of mercury (mmHg). The readings are always given in pairs, with the upper (systolic) value first, followed by the lower (diastolic) value. | 3rd Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Richmond Agitation-Sedation Scale (RASS) | Richmond Agitation-Sedation Scale is a medical scale used to assess the agitation or sedation level of a individual. Changes from the Baseline. Below 0 means drowsy and sedated, 0 means alert and calm and 1 or above 1 means restless & agitated | 3rd day | 
| Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) | Changes from the baseline. It will provide a qualitative result of delirium present or delirium absent. Clinical psychologist delirium is defined in terms of four diagnostic features, and is deemed present when a patient has positive Feature 1 and Feature 2 and either Feature 3 or 4. overall answer in Yes or No | 3rd Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BiPap, Respiratory failure, CPap, Respiratory Parameters, Hemodynamics