BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients

• ClinicalTrials.gov Identifier: NCT04020627
• Recruitment Status: Completed
• First Posted: July 16, 2019
• Last Update Posted: July 16, 2019
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Respiratory Failure	Other: BiPAP Group; Other: CPAP Group	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Acute Effects of BIPAP vs CPAP on Hemodynamics and Respiratory Parameters in Management of Type 2 Respiratory Failure Patients
• Actual Study Start Date: January 10, 2019
• Actual Primary Completion Date: May 10, 2019
• Actual Study Completion Date: June 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: BiPAP Group; Bilevel Positive Airway Pressure	Other: BiPAP Group; 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	Other: CPAP Group; 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Pakistan

Riphah International University

Islamabad, Federal, Pakistan, 44000

Sponsors and Collaborators

Riphah International University

Investigators

• Principal Investigator: Iqbal Tariq, MSCPPT; Riphah International University

More Information

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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT04020627
• Other Study ID Numbers: RiphahIU Shabana Kausar
• First Posted: July 16, 2019
• Last Update Posted: July 16, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riphah International University:

Respiratory failure; BiPap; CPap; Respiratory Parameters; Hemodynamics

Additional relevant MeSH terms:

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases