Clinical trial NCT05159401: The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State
Official title: The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State After Major Reconstructive Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: medical rehabilitation; oxygenation
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: There will be formed of groups for application of vibration methods on the lungs: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device; the method of oscillating PEP therapy using Acapella DH Green; the method of hardware stimulation of cough with a mechanical insufflator-aspirator Comfort Cough Plus (Comfortable cough Plus). As a control group, classical manual chest massage with percussion and verbal stimulation of cough against the background of chest compressions with a total duration of 15 minutes will be used

Detailed description: The patient signs an informed consent to participate in the study after 10-12 hours tracheal extubation and transfer of the patient to spontaneous respiration. The application of one or another method of influence is carried out by the method of random sampling (the envelope method). Next, a session is conducted using one of the methods of vibrational respiratory therapy. We are exploring the gas composition of arterial blood is examined, spirometry, and the respiratory rate is measured after 20 minutes of the procedure. Further, respiratory therapy sessions are repeated 3 times a day for three days

Eligibility criteria: Inclusion Criteria:

1. Age from 18 years to 80 years inclusive.
2. Performed cardiac surgery in IC conditions.
3. The patient's consent to participate in this study.

Exclusion Criteria:

1. Lack of productive contact with the patient
2. Any disorder in the central nervous system in the perioperative period (acute cerebrovascular accident, coma, posthypoxic encephalopathy), being on a ventilator.
3. Unstable hemodynamics or hemodynamically significant rhythm disturbances
4. Shocks of various etiologies
5. Inability to provide respiratory protection, high risk of aspiration
6. Refusal of the patient to participate in this study

Primary outcomes:
measure: the minute inspiratory lung volume
timeFrame: hospitalisation period, an average of 1 week
measure: arterial blood oxygenation level
timeFrame: hospitalisation period, an average of 1 day
measure: SpO2 more than 92%
timeFrame: hospitalisation period, an average of 3 day
Secondary outcomes:
measure: the number of complications
timeFrame: hospitalisation period, an average of 1 week
measure: assessment of the duration of hospital stay
timeFrame: hospitalisation period, an average of 1 week
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Research National Center of Surgery
Study officials:
affiliation: Head of the Intensive Care Unit
name: Alexander А Eremenko, prof
role: STUDY_DIRECTOR
affiliation: anesthesiologist-resuscitator
name: Darya Ryabova
role: PRINCIPAL_INVESTIGATOR
References: