Clinical trial NCT04733261: Diaphragmatic Mobility In Ventilated Assisted Patients
Official title: Effectiveness Of Diaphragmatic Mobility In Ventilated Assisted Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation Therapy; Complications
Keywords: Respiration, Artificial
Diaphragm
Physical Therapy Modalities
Ventilators, Mechanical
Intensive Care Units
Lead sponsor: Aqua Medical Services (Pvt) Ltd
Sponsor class: INDUSTRY
First posted: 2021-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was a randomized controlled trial. A total of 24 patients who met the inclusion criteria were included in this study and randomly divided by sealed envelope method into Experimental and Control groups with 12 patients each. Assessment of arterial blood gas analyzer (oxygen saturation(SP02), heart rate (HR), respiratory rate(RR), the partial pressure of carbon dioxide(PCO2), the partial pressure of oxygen(PO2), Bicarbonate(HCO3), and potential of hydrogen(PH) and modes of the ventilator (SIMV and PSV) for both groups were carried out at baseline and after 4thsession.The control group was given Chest physiotherapy only. While the Experimental group received Chest physiotherapy with Diaphragmatic Mobility. Total 4 sessions were given on alternate days to both groups.

Detailed description: Most common state in the intensive care unit is an intensive care unit acquired weakness in seriously unwell patients who are artificially ventilated for an extended period of time. The most important aspect of mechanical ventilation in the disuse atrophy and deconditioning of a patient's inspiratory muscle since it can replace the patient's own respiratory muscle exertion. The diaphragm particularly counters to persistent mechanical ventilation with atrophy. Most sufferers who are admitted to an intensive care unit need artificial aeration. Due to weaknesses of respiratory muscle might augment the interval of mechanical ventilation and delay the phase of withdrawal of mechanical ventilation. The term weaning is used for the course of withdrawal of artificial aeration to facilitate the patient's own respiratory muscle effort in the intensive care unit. Ventilation is universal work, linking the entire body, the emotions, the nervous system and organs. The diaphragm is the primary breathing muscle that influencing with its contraction the inspiratory actions. Diaphragmatic breathing is recognized as normal breathing which involves corresponding movement of abdomen, upper and lower ribcage. Furthermore, functionality and sufficient use of the diaphragm muscle requires usual breathing. Thoracic breathing is recognized as unusual breathing that involves aeration from the upper chest, evidence by bigger upper rib cage movement, compare to lower rib cage movement. Weakness possibly will owe an extreme weight on the respiratory muscle, which might affect starting augmented airway conflict and also over-come lung compliance. Two most important factors that are broadly known as a reason of malfunction to with-drawl from mechanical ventilation are weakness or fatigue of diaphragm and accessory muscle of respiration. A dome-shaped muscular membrane that separates the abdomen from thoracic is a diaphragm. Nine hundred centimetre per square area is covert in adults. It is the most important and primary inspiratory muscle and it is able to condense itself to forty per cent as of residual to vital capacity. In fact, a one-sided paralysis of the phrenic nerve generates merely respiratory dysfunction because the stomach has the widespread capacity to functional preserved. The weakness of diaphragm muscle tends to be more worse in patients who are mechanically ventilated for a prolonged period of time with controlled modes of mechanical ventilator compared to spontaneous modes and also appear to be interrelated to patients voluntary inspiratory exertion even as ventilator-dependent. During inspiration, throughout the application of resistance in inspiratory muscles that may help in strengthening of inspiratory muscle and this technique is known as inspiratory muscle training. Patients who have difficulty in breathing and mechanically ventilated for more than 24 hours possibly will adversely affect diaphragmatic structure and function. Major factors such as reduced quality of life, increase the length of stay in the intensive care unit, increase death rate and reduced functional grades are due to extended artificial aeration. Moreover, extended artificial aeration is cheap, unbearable a big portion of hospital assets and a healthcare load that might keep on subsequent hospital ejection. An intervention invented to directly stretch the muscle fibre of diaphragm is known as the manual diaphragm release technique. Even though this intervention is widely used in some regions, there is no quantitative research or systematic trails or evaluating the result of this technique. The previous research conducted to find out the outcome of manual diaphragm release technique in chronic obstructive pulmonary disease. The objective of the study was to determine the effects of diaphragmatic mobility on improving ventilation in ventilated assisted patients, to determine the effects of diaphragmatic mobility in weaning off from mechanical ventilation in ventilated assisted patients, and to determine the additional effects of diaphragmatic mobility on respiration along with Chest Physical Therapy.

Eligibility criteria: Inclusion Criteria:

* Age 30 to 60
* Oro-tracheal or nasotracheal intubate; ventilator mode:- Synchronized intermittent mechanical ventilation(SIMV) or Pressure support SIMV
* Both Gender included have been aeration used for Acute Respiratory Failure( type 2) during SIMV/PSV used for at any rate 72 hours consecutively
* Hemodynamically secure with no vasopressin or else inotropes (apart from a dobutamine and dopamine infusion lesser than 5 gamma/Kg/min and a 3 gamma /Kg/min, correspondingly
* Positive end-expiratory pressure 5 to 7cm H2O

Exclusion Criteria:

* Neurological or neuromuscular disorders
* Dysfunction of Phrenic Nerve
* Insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, oesophagal varies).
* Pulmonary embolism, Malignancy, Pneumothorax, trauma, fever
* Acutearrhythmias

Primary outcomes:
measure: Synchronized Intermittent- Mandatory Ventilation (SIMV)
timeFrame: 0 day
measure: Pressure Support Ventilation (PSV)
timeFrame: 0 day
measure: Synchronized Intermittent- Mandatory Ventilation (SIMV)
timeFrame: 4th day
measure: Pressure Support Ventilation (PSV)
timeFrame: 4th day
Secondary outcomes:
measure: Arterial Blood Gas ( ABGs) Test
timeFrame: 0 day,4th day
measure: Peripheral Capillary Oxygen Saturation (SPO2)
timeFrame: 0 day,4th day
measure: Chest X-ray
timeFrame: 0 day,4th day
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Aqua research Center
state: Federal
Study officials:
affiliation: Shifa Tameer e milat University
name: Dr Abdul Ghafoor Sajjad,, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019.
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