Evaluation of Comparative Efficacy of Graded Early Mobilization with Conventional Physiotherapy on Non-Invasive vs Invasive Mechanical Ventilation in COPD Patients with Acute Respiratory Failure: A Randomized Controlled Trial

The aim of the study is to assess the effect of Graded Early Mobilization with Conventional Physiotherapy on Non-Invasive Mechanically Ventilation and compare the effect with Mechanically Ventilation in COPD Patients with Acute Respiratory Failure on oxygenation, Fatigue, and ICU mobility.

Patient will be already diagnosed with COPD with Acute Respiratory Failure medically at the Tertiary care hospital by Arterial Blood Gas (ABG) by the clinician and referred for Physiotherapy. Then, the patient who is willing to participate in the study will be screened for inclusion and exclusion criteria. The patient’s family member will be provided with an adequate explanation of the proposed benefits, hazards, procedures, and treatment protocol included in the study in the language they understand best, and signed informed consent (Informed Assent) will be obtained in their native tongue. The participants were randomized (allocated) into two groups (group A and group B) using a computer-generated randomization list.

Group A – (Experimental Group) –    Graded Early Mobilization with Conventional Physiotherapy on  Non-Invasive Mechanical Ventilation

Group – B (Control Group) –             Graded Early Mobilization with Conventional Physiotherapy on Invasive Mechanical Ventilation

To assess the safety of the treatment session, all patients will be instructed to report any difficulty or problem before, during, or after it. Every intervention will be carried out under observation and control. Both the groups will be given the treatment. All the safety and aseptic measures will be followed during the treatment. Taking into consideration the critically ill patients assistance will be taken to monitor the vitals (ICU nurses). Using a pulse oximeter, the patients’ vital signs (heart rates, saturation) were continuously tracked. If the saturation will drop by more than 90%, the intervention will be stopped. Each patient will received individual care from a physiotherapist during the intervention. Patient will be observed for all the lines attached, any leakage from the source, temperature raise or any discomfort sign. Treatment will be given for 5 days two times a day, The medications and history of last feed was taken into consideration and all medical intervention will be continue as per instruction of doctor. Pre intervention and after 5 days post treatment will be documented. A statistical test will be performed after data collection.

Group A Intervention for the experimental group: - Graded Early Mobilization with Conventional Physiotherapy on Non- Invasive Mechanically Ventilation.

In this group all Non- Invasive mechanically Ventilated Patient will get Graded physiotherapy Protocol with Standard Physiotherapy.

Standard Physiotherapy: Received conventional chest physiotherapy treatment that included Percussion, Vibration, ACBT, Passive ROM Movements for bilateral upper and Lower limb, Bilateral tendo-Achillis stretch 2 times in a day.

Graded Early Mobilization - Early and progressive mobility protocol along with Standard Physiotherapy they will receive active mobilization exercises that focused on all the joints including upper back, shoulder, trunk. The patients will ask to perform daily life activities like shifting the bottle from right to left. Picking up an object by bending down, pulling a string as well as pushing an object for resistance to the muscles, the progression will be making patient sit with back straight without support, once that will achieve, patient will be progressed to edge of bed sitting according to patients’ tolerance level. The intervention protocol and its progression will be according to the ten strategies to optimize early mobilization as published protocol in 2020 by Aishwarya Gatty, with some modifications made according to the outcomes expected.  Scoring will be done immediately post-mobilization sessions. Mobilization session on a particular day will be stopped if patients met any criteria for discontinuation. Safety criteria, red flags and termination criteria will be followed.  As standard physiotherapy will be given two times a day and early mobilization will be given one time in a day total for 5 days.

Group B Intervention for the control group: - Graded Early Mobilization with Conventional Physiotherapy on Invasive Mechanically Ventilation. In this group all Invasive mechanically Ventilated Patient will get Graded physiotherapy Protocol with Standard Physiotherapy.  In this control group will receive same treatment as experimental group receive but patients will be Invasively Mechanically Ventilated.