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BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients

Primary Purpose

Type 2 Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
BiPAP Group
CPAP Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Respiratory Failure focused on measuring Respiratory failure, BiPap, CPap, Respiratory Parameters, Hemodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BiPAP Group

CPAP Group

Arm Description

Bilevel Positive Airway Pressure

Continuous Positive Airway Pressure

Outcomes

Primary Outcome Measures

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
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
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
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
Heart Rate
Changes from the Baseline, It will be measured through Cardiac Monitor
Saturation (SPO2)
Changes from the Baseline, It will be measured in percentage through Cardiac Monitor.
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.
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
July 13, 2019
Last Updated
July 13, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04020627
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Respiratory Failure
Keywords
Respiratory failure, BiPap, CPap, Respiratory Parameters, Hemodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BiPAP Group
Arm Type
Experimental
Arm Description
Bilevel Positive Airway Pressure
Arm Title
CPAP Group
Arm Type
Experimental
Arm Description
Continuous Positive Airway Pressure
Intervention Type
Other
Intervention Name(s)
BiPAP Group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
CPAP Group
Intervention Description
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 Outcome Measure Information:
Title
Arterial blood gas (ABG) parameter like potential of hydrogen (PH)
Description
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
Time Frame
3rd Day
Title
Arterial blood gas parameter like bicarbonate(HCO3).
Description
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
Time Frame
3rd Day
Title
Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)
Description
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
Time Frame
3rd Day
Title
Arterial blood gas parameter like partial pressure of carbon dioxide (PO2)
Description
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
Time Frame
3rd Day
Title
Heart Rate
Description
Changes from the Baseline, It will be measured through Cardiac Monitor
Time Frame
3rd Day
Title
Saturation (SPO2)
Description
Changes from the Baseline, It will be measured in percentage through Cardiac Monitor.
Time Frame
3rd Day
Title
Systolic Blood Pressure (SBP)
Description
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.
Time Frame
3rd day
Title
Diastolic Blood Pressure (SBP)
Description
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.
Time Frame
3rd Day
Secondary Outcome Measure Information:
Title
Richmond Agitation-Sedation Scale (RASS)
Description
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
Time Frame
3rd day
Title
Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Description
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
Time Frame
3rd Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal Tariq, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11867822
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.
Results Reference
background
PubMed Identifier
9700176
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.
Results Reference
background
PubMed Identifier
12789060
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.
Results Reference
background
PubMed Identifier
28977203
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
27771274
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.
Results Reference
background
PubMed Identifier
8804944
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.
Results Reference
background
PubMed Identifier
12660387
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.
Results Reference
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BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients

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