Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient

Corona Virus Infection Clinical Trial

— COVID19  

Official title:

Effect of Active Cycle Breathing Technique Along With Incentive Spirometer on COVID19 Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517941
• Other study ID #: p.t.REC/012/003416
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study will be conducted to investigate the effect of Active Cycle Breathing Technique and incentive spirometer on COVID19 patient

Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus that emerged in 2019 and causes coronavirus disease 2019 (COVID-19).Individuals with COVID-19 can present with an influenza-like illness and respiratory tract infection demonstrating fever (89%),cough (68%), fatigue (38%), sputum production (34%) and/or shortness of breath (19%). The spectrum of disease severity ranges from asymptomatic infection or mild upper respiratory tract illness through to severe viral pneumonia with respiratory failure and/or death. Current reports estimate that 80% of cases are asymptomatic or mild; 15% of cases are severe (infection requiring oxygen); and 5% are critical, requiring ventilation and life support. Based on emerging data, individuals at the highest risk of developing severe COVID-19 disease requiring hospitalization and/or ICU support are those who are older, male, have at least one co-existing comorbidity, elevated D-dimer levels, and/or lymphocytopenia. Active cycle breathing techniques (ACBT) is a cycle of techniques consisting of breathing control, lower thoracic expansion exercises and the forced expiration technique modifiable to individual patients. It assists bronchial clearance by enhancing mucociliary clearance whilst reducing adverse effects such as hypoxemia or increased airflow obstruction. Incentive spirometry (IS) is a type of deep breathing exercise that is widely used for lung expansion and the prevention of pulmonary complications in children, adults, and the elderly. IS is used to encourage the patient to inhale to lung capacity through maximal inspiration aided with visual feedback. These maneuvers increase transpulmonary pressure and therefore increase chest-wall volume.one hundred patients will be allocated randomly to two groups; one group will receive active cycle breathing with an incentive spirometer and the other will receive active cycle breathing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ages from 45-75 years old

• COVID-19 patients with SpO2 > 85

• oxygen face Mask or a reservoir mask

Exclusion Criteria:

• Mechanically ventilated,

• Cancer,

• Chronic respiratory disease (defined as asthma or chronic obstructive pulmonary disease),

• End-stage renal disease,

• Liver disease (defined as compensated/decompensated liver cirrhosis),

• Chronic neurological disease (defined as previous neurological disease),

• Chronic cardiovascular disease,

• Active smoker

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19

Intervention

Other:
• active cycle breathing
The active cycle breathing technique will involve three steps: breathing control, thoracic expansion exercise, and forced expiration technique, In breathing control, the patient will sit comfortably in a chair and breathe at a normal rate and depth using the lower chest. In the thoracic expansion exercise, the physical therapist rested his/her hands on the patient's epigastrium and guided the patient's breathing so that they breathed at a slow and deep rate using the lower chest, then held their breath for 2 s and fully exhaled; this was repeated two or three times, then the patient returned to breathing control. For the forced expiration technique, the physical therapist asked the patient to inhale deeply while simultaneously contracting the abdominal muscle and keeping the mouth and throat open. They then held their breath for 2 s, followed by vigorous exhalation
• incentive spirometer
Incentive spirometry is accomplished by using a device that provides feedback when the patient inhales at a predetermined flow and sustains the inflation for at least 5 seconds. The patient is instructed to hold the spirometer in an upright position, exhale normally, and then place the lips tightly around the mouthpiece. The next step is a slow inhalation to raise the ball (flow-oriented) or the piston/ plate (volume-oriented) in the chamber to the set target. At maximum inhalation, the mouthpiece is removed, followed by a breath-hold and normal exhalation.

Locations

Country	Name	City	State
Egypt	El sheikh zayed Al nahyan hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial blood gas	arterial blood gas analysis will be measured using arterial blood sample	up to two weeks
Secondary	C-reactive protein	C-reactive protein will be measured by blood sample analysis	up to two weeks
Secondary	Oxygen saturation	SpO2 will be measure by pulse oximeter	up to two weeks