NCT04733261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

December 22, 2020

Last Update Submit

September 2, 2021

Conditions

Keywords

Respiration, ArtificialDiaphragmPhysical Therapy ModalitiesVentilators, MechanicalIntensive Care Units

Outcome Measures

Primary Outcomes (4)

  • Synchronized Intermittent- Mandatory Ventilation (SIMV)

    Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort

    0 day

  • Pressure Support Ventilation (PSV)

    For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).

    0 day

  • Synchronized Intermittent- Mandatory Ventilation (SIMV)

    Synchronized intermittent mandatory ventilation is a ventilator mode that enables partial mechanical assistance. This ventilator mode will provide a set number of breaths at a fixed tidal volume, but a patient can trigger a spontaneous breath with the volume determined by patient effort

    4th day

  • Pressure Support Ventilation (PSV)

    For the spontaneously breathing patient, pressure support ventilation (PSV) has been advocated to limit barotrauma and to decrease the work of breathing. ... Airway pressure support is maintained until the patient's inspiratory flow falls below a certain cutoff (eg, 25% of peak flow).

    4th day

Secondary Outcomes (3)

  • Arterial Blood Gas ( ABGs) Test

    0 day,4th day

  • Peripheral Capillary Oxygen Saturation (SPO2)

    0 day,4th day

  • Chest X-ray

    0 day,4th day

Study Arms (2)

Diaphragmatic mobility

ACTIVE COMPARATOR

The patient will be in supine, supported on one/two pillows under her head, and a bolster under her knees.

Other: Diaphragmatic mobility

Chest Physiotherapy

EXPERIMENTAL

Give passive ROM exercise to all joints of the upper and lower extremities.

Other: Chest Physiotherapy

Interventions

Therapist will manually make contact with Pisiform Hypothenar region and last three fingers among the underneath the costal cartilage of the 7th in the direction of 10 ribs. For the duration of participant's inhalation, the counselor drag softly within a upward course accompany the increase motion of the ribs. For the period of expiration, the counselor will deepens make contact with in the direction of the internal costal border. Taking place consequent breathing, the counselor wanted on the way to expand traction as well as slickly make deeper the contact.

Diaphragmatic mobility

Patients allocated to the control group and interventional group received pulmonary rehabilitation two times a day beginning happening the day of entrance on the way to the intensive care unit. It consists of side-lying positioning with the head of the bed horizontal for at least 20 min with the most affected lung on chest x-ray positioned uppermost is also known as postural drainage, 4 sets of 6 cycles of expiratory chest wall vibrations , and airway suctioning at least three times through the endotracheal and tracheotomy tube disperse in the course of the management

Chest Physiotherapy

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aqua research Center

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (8)

  • Jounieaux V, Duran A, Levi-Valensi P. Synchronized intermittent mandatory ventilation with and without pressure support ventilation in weaning patients with COPD from mechanical ventilation. Chest. 1994 Apr;105(4):1204-10. doi: 10.1378/chest.105.4.1204.

    PMID: 8162750BACKGROUND
  • Hodgson CL, Tipping CJ. Physiotherapy management of intensive care unit-acquired weakness. J Physiother. 2017 Jan;63(1):4-10. doi: 10.1016/j.jphys.2016.10.011. Epub 2016 Nov 26.

    PMID: 27989729BACKGROUND
  • Bordoni B, Marelli F, Morabito B, Sacconi B. Manual evaluation of the diaphragm muscle. Int J Chron Obstruct Pulmon Dis. 2016 Aug 18;11:1949-56. doi: 10.2147/COPD.S111634. eCollection 2016.

    PMID: 27574419BACKGROUND
  • Moodie L, Reeve J, Elkins M. Inspiratory muscle training increases inspiratory muscle strength in patients weaning from mechanical ventilation: a systematic review. J Physiother. 2011;57(4):213-21. doi: 10.1016/S1836-9553(11)70051-0.

    PMID: 22093119BACKGROUND
  • Bissett B, Leditschke IA, Green M, Marzano V, Collins S, Van Haren F. Inspiratory muscle training for intensive care patients: A multidisciplinary practical guide for clinicians. Aust Crit Care. 2019 May;32(3):249-255. doi: 10.1016/j.aucc.2018.06.001. Epub 2018 Jul 11.

    PMID: 30007823BACKGROUND
  • Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.

    PMID: 26386894BACKGROUND
  • 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.

    PMID: 30719351BACKGROUND
  • Yang PH, Wang CS, Wang YC, Yang CJ, Hung JY, Hwang JJ, Wang TH, Chuang IC, Huang MS. Outcome of physical therapy intervention on ventilator weaning and functional status. Kaohsiung J Med Sci. 2010 Jul;26(7):366-72. doi: 10.1016/S1607-551X(10)70060-7.

    PMID: 20638039BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Abdul Ghafoor Sajjad,, PHD*

    Shifa Tameer e milat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 22, 2020

First Posted

February 2, 2021

Study Start

March 15, 2020

Primary Completion

February 15, 2021

Study Completion

February 28, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations