Clinical trial NCT04020627: BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients
Official title: Acute Effects of BIPAP vs CPAP on Hemodynamics and Respiratory Parameters in Management of Type 2 Respiratory Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Respiratory Failure
Keywords: Respiratory failure
BiPap
CPap
Respiratory Parameters
Hemodynamics
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Arterial blood gas (ABG) parameter like potential of hydrogen (PH)
timeFrame: 3rd Day
measure: Arterial blood gas parameter like bicarbonate(HCO3).
timeFrame: 3rd Day
measure: Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)
timeFrame: 3rd Day
measure: Arterial blood gas parameter like partial pressure of carbon dioxide (PO2)
timeFrame: 3rd Day
measure: Heart Rate
timeFrame: 3rd Day
measure: Saturation (SPO2)
timeFrame: 3rd Day
measure: Systolic Blood Pressure (SBP)
timeFrame: 3rd day
measure: Diastolic Blood Pressure (SBP)
timeFrame: 3rd Day
Secondary outcomes:
measure: Richmond Agitation-Sedation Scale (RASS)
timeFrame: 3rd day
measure: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
timeFrame: 3rd Day
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.