Concurrent Trigger Sensitivity Adjustment And Diaphragmatic Facilitation On Weaning From Mechanical Ventilation

NCT ID: NCT05387720

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-11-30

Brief Summary

As Acute respiratory failure (ARF) is a challenging serious condition especially when it necessitates intubation to deliver mechanical ventilation which is a fundamental strategy for supporting the respiratory function when the patient can't bear all work of breathing. Even if it represents a life-saving procedure, mechanical ventilation (MV) is associated to life-threatening complications as respiratory muscle dysfunction, and atrophy that lead to long stay in intensive care unit (ICU) and higher mortality. Weaning difficulty is experienced in nearly 30 percent of critically ill patients.

The decision to extubate mechanically ventilated patients should be aimed at preventing both the risk of premature liberation from MV which is associated with poor outcome and the risk of delayed extubation which increases the complications of prolonged MV and there is increasing evidence that MV itself may adversely affect the diaphragm's structure and function, which has been termed ventilator-induced diaphragmatic dysfunction (VIDD). The combination of positive pressure ventilation and positive end-expiratory pressure may unload the diaphragm which leads to changes in myofibril length and rapid atrophy that occurs within hours of MV, caused by an imbalance between protein synthesis and proteolysis, lead to a large reduction in the inspiratory pressure generated by the diaphragm.

Detailed Description

Physiotherapist is a key member of multidisciplinary team and plays an vital role in ICU in improving the patient's quality of life, Inspiratory muscle training (IMT) applies a load to the diaphragm and accessory inspiratory muscles to increase their strength and endurance. Adjustment of ventilator sensitivity provides resistance and hence a pressure load to the inspiratory muscles, and proprioceptive neuromuscular facilitation (PNF) of respiration is newly introduced in ICU for patients who are ventilator dependent by use of external proprioceptive and tactile stimuli to assist respiration. PNF techniques improve inspiration and expiration in next cycle that shows improvement with active initiation or more participation in respiration to alter the rate and depth of breathing, facilitate respiratory muscles, improve breathing pattern and increase tidal volume So the purpose of this study is to determine the concurrent effect of trigger sensitivity adjustment and diaphragmatic facilitation on weaning of patients from mechanical ventilation. As the patients may gain a more benefit from the combination of trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniques than from each one alone. Therefore, a concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) techniques must likely be started within 24 to 48 hours of initiating MV to protect diaphragm from atrophy, facilitate faster weaning, minimize ICU stay and cost of treatment, and decrease the morbidity and mortality rate of those patients admitted to ICU.

Study Hypothesis:

It will be hypothesized that there is no effect of diaphragmatic facilitation on weaning of patients from mechanical ventilation.

It will be hypothesized that there is no effect of trigger sensitivity adjustment on weaning of patients from mechanical ventilation.

It will be hypothesized that there is no effect of a concurrent trigger sensitivity adjustment and diaphragmatic facilitation on weaning of patients from mechanical ventilation.

Conditions

Acute Respiratory Failure; Mechanically Ventilated Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Group A

Study Group A (25 patients) will receive manual diaphragmatic facilitation (PNF) technique in addition to traditional chest physiotherapy

Group Type: ACTIVE_COMPARATOR

Manual diaphragmatic facilitation (PNF) technique

Intervention Type: PROCEDURE

Diaphragmatic PNF is a facilitator technique used to improve chest expansion, increase epigastric excursion, promote breathing frequency and depth, by applying external proprioceptive tactile stimuli over diaphragm. The therapist places the thumbs toward the xiphoid process and the fingers along the costal margins of the lower ribs and pushing deep to stimulate the diaphragm During inspiration, the patient will be instructed "take a deep breath breathe in" and the therapist assists the movement to promote the subject's respiratory pattern in downward movement. At the maximum inspiration, therapist will say "hold your breath for 5 seconds". The therapist gives mild resistance to the inferior movement of the contracting diaphragm during inspiration while pushing diaphragm superiorly. During expiration, therapist says "breathe out" and pushed under lower ribs on both sides upward to assist the discharge of air remaining in the lungs.

Study Group B

Study Group B (25 patients) will receive trigger sensitivity adjustment on mechanical ventilator in addition to traditional chest physiotherapy.

Group Type: ACTIVE_COMPARATOR

Trigger sensitivity adjustment on mechanical ventilation

Intervention Type: PROCEDURE

The pressure trigger sensitivity will be adjusted to 20% of the first recorded MIP at the start of training by decreasing trigger sensitivity towards negative pressure. In the first session, inspiratory muscle training (IMT) will be limited to 5 min; afterwards the duration will be increased by 5 min at every session until it reaches 30 min. If a patient tolerates 30 min of IMT, The next session will be performed with increasing negative pressure of the trigger sensitivity by 10% of the initial MIP. The maximal acceptable intensity is 40% of MIP, Patients who can't tolerate IMT with 20% of MIP for 5 min will be trained with 10% of MIP

Study Group C

Study Group C (25 patients) will receive a concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique in addition to traditional chest physiotherapy.

Group Type: ACTIVE_COMPARATOR

concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique

Intervention Type: PROCEDURE

Diaphragmatic PNF technique will be applied synchronously in the same time, on each breath with trigger sensitivity adjustment on mechanical ventilation in same manner as discussed before

Interventions

Manual diaphragmatic facilitation (PNF) technique

Diaphragmatic PNF is a facilitator technique used to improve chest expansion, increase epigastric excursion, promote breathing frequency and depth, by applying external proprioceptive tactile stimuli over diaphragm. The therapist places the thumbs toward the xiphoid process and the fingers along the costal margins of the lower ribs and pushing deep to stimulate the diaphragm During inspiration, the patient will be instructed "take a deep breath breathe in" and the therapist assists the movement to promote the subject's respiratory pattern in downward movement. At the maximum inspiration, therapist will say "hold your breath for 5 seconds". The therapist gives mild resistance to the inferior movement of the contracting diaphragm during inspiration while pushing diaphragm superiorly. During expiration, therapist says "breathe out" and pushed under lower ribs on both sides upward to assist the discharge of air remaining in the lungs.

Intervention Type: PROCEDURE

Trigger sensitivity adjustment on mechanical ventilation

The pressure trigger sensitivity will be adjusted to 20% of the first recorded MIP at the start of training by decreasing trigger sensitivity towards negative pressure. In the first session, inspiratory muscle training (IMT) will be limited to 5 min; afterwards the duration will be increased by 5 min at every session until it reaches 30 min. If a patient tolerates 30 min of IMT, The next session will be performed with increasing negative pressure of the trigger sensitivity by 10% of the initial MIP. The maximal acceptable intensity is 40% of MIP, Patients who can't tolerate IMT with 20% of MIP for 5 min will be trained with 10% of MIP

Intervention Type: PROCEDURE

concurrent trigger sensitivity adjustment and manual diaphragmatic facilitation (PNF) technique

Diaphragmatic PNF technique will be applied synchronously in the same time, on each breath with trigger sensitivity adjustment on mechanical ventilation in same manner as discussed before

Intervention Type: PROCEDURE

Other Intervention Names

Diaphragmatic PNF; Trigger sensitivity

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes with age ranges (50-60) years old.
• Patients will be referred with acute respiratory failure (ARF) inside ICU.
• All patients are intubated and mechanically ventilated with assisted control (pressure or volume) or pressure support modes for 24-48 hours.
• All patients with positive end expiratory pressure (PEEP) don't exceed 10 cmH2o.
• All patients are hemodynamically stable; temperature (36.2-37.5) C, Heart rate < 140 /min, Blood pressure (systolic: <180mmHg and diastolic <100 mmHg), Respiratory rate < 35/min and oxygen saturation >90%
• All patients are conscious and responsive to verbal command.

Exclusion Criteria

• Fraction of inspired oxygen (fio2)>0.6 and SPO2 < 85% to avoid further hypoxia and respiratory distress.
• Positive end expiratory pressure (PEEP) > 10 cmH2O to avoid barotrauma.
• Severe pulmonary condition; acute pulmonary embolism, undrained pneumothorax.
• Unstable hemodynamic condition as defined by heart rate more than 140 beats/min, systolic blood pressure >180 mmHg or Low blood pressure < 80 mmHg and respiratory rate is exceeding 35 breaths/min.
• Patients who develop any cardiac condition during the course of treatment; acute myocardial infarction or cardiac arrhythmia.
• Patients who recently have undergo cardiac or abdominal or gynecological surgery.
• Active lung infection like tuberculosis.
• Chest trauma such as rib fracture, flail chest, thoracic vertebra fracture or chest burns.
• Spinal cord injuries involved the phrenic nerve.
• Active bleeding as alveolar hemorrhage, hemoptysis.
• Heavy sedation that depresses respiratory drive or ability to follow commands.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Badran Mohamed Ismail

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hany E Obaya, PHD

Role: STUDY_CHAIR

Cairo University

El sayed E El sayed, PHD

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of physical therapy - Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/002902

Identifier Type: -

Identifier Source: org_study_id