- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04020627
BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients
Acute Effects of BIPAP vs CPAP on Hemodynamics and Respiratory Parameters in Management of Type 2 Respiratory Failure Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Federal
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Islamabad, Federal, Pakistan, 44000
- Riphah international university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BiPAP Group
Bilevel Positive Airway Pressure
|
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 |
Experimental: CPAP Group
Continuous Positive Airway Pressure
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3rd Day
|
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
|
3rd Day
|
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
|
3rd Day
|
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
|
3rd Day
|
Heart Rate
Time Frame: 3rd Day
|
Changes from the Baseline, It will be measured through Cardiac Monitor
|
3rd Day
|
Saturation (SPO2)
Time Frame: 3rd Day
|
Changes from the Baseline, It will be measured in percentage through Cardiac Monitor.
|
3rd Day
|
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.
|
3rd day
|
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.
|
3rd Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3rd day
|
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
|
3rd Day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available.
- Antonelli M, Conti G, Rocco M, Bufi M, De Blasi RA, Vivino G, Gasparetto A, Meduri GU. A comparison of noninvasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med. 1998 Aug 13;339(7):429-35. doi: 10.1056/NEJM199808133390703.
- Pelosi P, Severgnini P, Aspesi M, Gamberoni C, Chiumello D, Fachinetti C, Introzzi L, Antonelli M, Chiaranda M. Non-invasive ventilation delivered by conventional interfaces and helmet in the emergency department. Eur J Emerg Med. 2003 Jun;10(2):79-86. doi: 10.1097/00063110-200306000-00002.
- Pieczkoski SM, Margarites AGF, Sbruzzi G. Noninvasive Ventilation During Immediate Postoperative Period in Cardiac Surgery Patients: Systematic Review and Meta-Analysis. Braz J Cardiovasc Surg. 2017 Jul-Aug;32(4):301-311. doi: 10.21470/1678-9741-2017-0032.
- Mehta Y, Vats M, Kumar SK, Singh S, Khurana P, Trehan N. Prevention of postoperative atelectasis in the post-cardiac surgical patient with poor left ventricular function: A study of the efficacy of Bi-level positive airway pressure. Chest. 2017 Oct 1;132(4):537A
- Olper L, Bignami E, Di Prima AL, Albini S, Nascimbene S, Cabrini L, Landoni G, Alfieri O. Continuous Positive Airway Pressure Versus Oxygen Therapy in the Cardiac Surgical Ward: A Randomized Trial. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):115-121. doi: 10.1053/j.jvca.2016.08.007. Epub 2016 Aug 10.
- Barbe F, Togores B, Rubi M, Pons S, Maimo A, Agusti AG. Noninvasive ventilatory support does not facilitate recovery from acute respiratory failure in chronic obstructive pulmonary disease. Eur Respir J. 1996 Jun;9(6):1240-5. doi: 10.1183/09031936.96.09061240.
- Kaneko Y, Floras JS, Usui K, Plante J, Tkacova R, Kubo T, Ando S, Bradley TD. Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. N Engl J Med. 2003 Mar 27;348(13):1233-41. doi: 10.1056/NEJMoa022479.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU Shabana Kausar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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