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NCT Number: NCT04020627

BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Islamabad, Federal, 44000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BiPAP Group

Other

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

CPAP Group

Other

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

Primary outcomes

  1. Arterial blood gas (ABG) parameter like potential of hydrogen (PH)

    Time frame: 3rd Day

    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

  2. Arterial blood gas parameter like bicarbonate(HCO3).

    Time frame: 3rd Day

    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

  3. Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)

    Time frame: 3rd Day

    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

  4. Arterial blood gas parameter like partial pressure of carbon dioxide (PO2)

    Time frame: 3rd Day

    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

  5. Heart Rate

    Time frame: 3rd Day

    Changes from the Baseline, It will be measured through Cardiac Monitor

  6. Saturation (SPO2)

    Time frame: 3rd Day

    Changes from the Baseline, It will be measured in percentage through Cardiac Monitor.

  7. Systolic Blood Pressure (SBP)

    Time frame: 3rd day

    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.

  8. Diastolic Blood Pressure (SBP)

    Time frame: 3rd Day

    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.

Secondary outcomes

  1. Richmond Agitation-Sedation Scale (RASS)

    Time frame: 3rd day

    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

  2. Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

    Time frame: 3rd Day

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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