BIPAP vs CPAP Effects on Type 2 Respiratory Failure Patients

NCT04020627 | Completed DMC

• 1 other identifier: RiphahIU Shabana Kausar
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Respiratory Failure

Keywords

Respiratory failure; BiPap; CPap; Respiratory Parameters; Hemodynamics

Outcome Measures

Primary Outcomes (8)

• 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

  3rd Day

• 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

  3rd Day

• 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

  3rd Day

• 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

  3rd Day

• Heart Rate

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

  3rd Day

• Saturation (SPO2)

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

  3rd Day

• 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.

  3rd day

• 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.

  3rd Day

Secondary Outcomes (2)

• Richmond Agitation-Sedation Scale (RASS)

  3rd day

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

  3rd Day

Study Arms (2)

BiPAP Group

EXPERIMENTAL

Bilevel Positive Airway Pressure

Other: BiPAP Group

CPAP Group

EXPERIMENTAL

Continuous Positive Airway Pressure

Other: CPAP Group

Interventions

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

BiPAP Group

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

CPAP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Person with Surgical Emphysema
• Pneumothorax
• Medically unstable (hypotensive shock, uncontrolled cardiac ischemia, or arrhythmia
• Person with Bulla's disease
• Severe bronchospasm

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (8)

• 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.

  PMID: 11867822 BACKGROUND

• 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.

  PMID: 9700176 BACKGROUND

• 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.

  PMID: 12789060 BACKGROUND

• 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.

  PMID: 28977203 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 27771274 BACKGROUND

• 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.

  PMID: 8804944 BACKGROUND

• 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.

  PMID: 12660387 BACKGROUND

MeSH Terms

Conditions

Hypoventilation; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iqbal Tariq, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 16, 2019
• Study Start: January 10, 2019
• Primary Completion: May 10, 2019
• Study Completion: June 10, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)