Clinical trial NCT05977166: Hyperbaric on Pulmonary Functions in Post Covid -19 Patients.
Official title: Influence of Hyperbaric Oxygen on Pulmonary Functions in Post Covid-19 Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19 Patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of the study is to investigate the effect of hyperbaric oxygen on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients, The effect of breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients.and the difference between the effect of hyperbaric and breathing exercises in form of diaphragmatic breathing exercise and pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and anticoagulation drugs on FVC, FEV1 and on oxygen saturation in post-COVID-19 patients

Seventy two covid-19 patients from both genders ranged in age chronology from twenty one to sixty six years will be conducted to participate in this study .Selection of the study sample and evaluate of pulmonary functions improvement as well as hyperbaric oxygen therapy will be conducted at Agriculture Hospital in El Mansoura town.

The study sample will be divided randomly into two equal groups of(A\&B).All patients participated in the current study will receive breathing excesses in form of Diaphragmatic breathing exercise and Pursed lip breathing with traditional medical treatment in form of (vitamin D, vitamin C and Anticoagulation drugs ,group A will receive 60 minutes of HBOT(100%oxygen at 2 ATA with five minutes air breaks every twenty minutes daily in morning for three weeks then take period time of rest about 30 minutes before starting breathing exercise.

The Body mass index (BMI) of each participated patient will be determined by measuring weight/ Kg and height/ m2 using Electronic weight and height scale to include BMI 25.0-29.9 Kg/ . Also using Digital spirometer SMP 21/01 RD (Russian) for measuring of FVC parameters , to be less than 80% ,FEV1 to be less than 80% and Pulse Oximeter for measuring Oxygen saturation to range from 90%to 95% assessment will be done before and after treatment.

The obtained results of this study will measure Forced vital capacity (FVC), Forced expiratory volume (FEV1) and oxygen saturation to determine the significant improvement of participated patients.


Eligibility criteria: Inclusion Criteria

* 1. post Covid -19 patients (2weeks after recovery).

  2.post Covid -19 patients with deficiency in forced vital capacity (less than 80%) forced expiratory volume (less than 80%) lower oxygen saturation (90%-95%).

  3.age (21-66)years old.

  4.both gender.

  5.BMI 25.0-29.9.

Exclusion Criteria:

1. COPD or other respiratory diseases.
2. Neurological disease.
3. mental illness.
4. Critically ill patients with intubation.
5. smokers.
6. Inner ear diseases.
7. pregnancy.

Primary outcomes:
measure: forced vital capacity,
timeFrame: 3 Months
measure: forced expiratory volume
timeFrame: 3 Months
measure: oxygen saturation
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: physiothyrapist at kafer Elshikh general Hospital
name: Enas Faraman
role: PRINCIPAL_INVESTIGATOR
References: