NCT05128552

Brief Summary

This study was conducted to investigate the effect of the LVR technique on cough ineffectiveness, to determine its benefit as a simple, safe, and inexpensive cough augmentation technique, and to determine how much the LVR method, for augmenting CPF, is useful in enhancing the success of extubation and reducing the rate of reintubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

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

December 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

October 29, 2021

Last Update Submit

November 18, 2021

Conditions

Keywords

Cough peak flowLung volume recruitmentAir stackingCough efficacyPost extubated patientRespiratory therapyIntensive care unitMechanical ventilation

Outcome Measures

Primary Outcomes (3)

  • Cough peak flow rate

    The maximum expiratory flow produced immediately after the glottis opens during a physiological cough

    "Day 4"

  • Peak expiratory flow rate

    The maximum rate at which the air can be expired after a deep inspiration

    "Day 4"

  • Oxygen Saturation

    The percentage that represents how haemoglobin are saturated with oxygen atoms

    "Day 4"

Secondary Outcomes (1)

  • Extubation's success

    "Day 4"

Study Arms (2)

Study group

EXPERIMENTAL

Twenty-five patients who received traditional chest physiotherapy and LVR technique for 30-45 minutes for successive 4 Days after extubation

Device: Lung volume recruitment techniqueOther: Traditional chest physiotherapy

Control group

ACTIVE COMPARATOR

Twenty-five patients who received only traditional chest physiotherapy for 30 minutes at least for successive 4 Days after extubation

Other: Traditional chest physiotherapy

Interventions

A self inflating Ambu bag with one way valve , augmentation volume of air within 3 to 4 successive breaths and holding few seconds then coughing

Also known as: Air stacking or breath stacking technique
Study group

Positioning of the patient according the drainage position for each lobe of each lung and applying airway hygiene techniques such as percussion and vibration

Control groupStudy group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Forty to sixty years old patients had undergone mechanical ventilation for ≥ 48 hours in a controlled mode and had been weaned after a successful spontaneous breathing trial with suboptimal or poor CPF \< 270 L/min.
  • Patients were able to assume a sitting position.
  • All participants were aware, cooperative, competent, able to comply with treatment, and able to understand and follow instructions.

You may not qualify if:

  • Presence of significant or active hemoptysis, untreated or recent pneumothorax, bullous emphysema, lung trauma, or recent lobectomy.
  • Patients with comorbidities interfering and compromising the success of either weaning or extubation, like cardiac arrhythmia, pericardial effusion, congestive heart failure, or acute coronary syndrome.
  • Patients who had originally inadequate training performance of the respiratory muscle such as those having NMD, i.e., myopathy or neuropathy.
  • Impaired consciousness/inability to communicate.
  • Patients who had a neurological deficit resulted in bulbar affection.
  • Patients with indications for MV, but contraindicated for physical therapy like pulmonary embolism.
  • Patients who had undergone tracheotomy before extubation also were excluded or who had experienced less than 24 hours of mechanical ventilation.
  • Patients with unstable hemodynamics or cardiac instability.
  • Current undrained pleural effusion or previous pneumothorax or barotrauma.
  • Uncontrolled severe COPD, poorly controlled asthma, and severe bronchospasm.
  • Patients with visual or/and auditory problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo University

Cairo, Giza Governorate, Egypt

Location

Related Publications (2)

  • Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.

    PMID: 28075489BACKGROUND
  • Rose L, Adhikari NK, Poon J, Leasa D, McKim DA; CANuVENT Group. Cough Augmentation Techniques in the Critically Ill: A Canadian National Survey. Respir Care. 2016 Oct;61(10):1360-8. doi: 10.4187/respcare.04775. Epub 2016 Sep 13.

    PMID: 27624630BACKGROUND

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mahmoud S. Ragab, Bsc

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICU Physical Therapist

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 22, 2021

Study Start

December 15, 2020

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations