- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05128552
Effect of Lung Volume Recruitment Technique After Extubation
Effect of Lung Volume Recruitment Technique on Cough Efficacy in Postextubated Patients With Ineffective Cough
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An effective cough is so vital in protecting against respiratory tract infections, so the importance of an intact cough mechanism is reflected in the occurrence of pulmonary problems which are the most common cause of hospital admission in people with respiratory muscle weakness who are unable to cough effectively. Ineffective cough results in a tendency to retain bronchial secretions and an increased risk of pulmonary complications, such as frequent or recurrent pneumonia, atelectasis, and infectious respiratory problems.
Cough flow testing (expiratory flows testing) is useful as a monitoring or diagnostic tool in clinical practice and research. Both peak expiratory flows (PEF) and cough peak flows (CPF) have been described as useful clinical measures of respiratory muscle function and cough effectiveness. Cough peak flow (CPF) gives an important measure of the cough strength which determines the effectiveness of cough. It is the maximum expiratory flow recorded immediately following the opening of the glottis during normal cough. Cough effectiveness is suboptimal when cough peak flow (CPF) is less than 270 L/min.
Mechanical Ventilation "MV" has deleterious effects caused by the endotracheal intubation, including changes in mucociliary clearance and inhibition of the coughing mechanism which, in turn, favor areas of hypoventilation and atelectasis, thus increasing the risk of ventilator-associated pneumonia. Respiratory compromise due to recurrent atelectasis, inability to clear secretions, and respiratory infections also increase morbidity and mortality. Prolonged MV results in respiratory muscle dysfunction shown in diaphragmatic atrophy and contractile dysfunction (ic., Ventilator-induced diaphragmatic dysfunction "VIDD") affecting the ability of the person to cough effectively. Indeed, the onset of VIDD in both animals and humans is rapid as significant diaphragmatic atrophy and contractile dysfunction occur within the first 24 - 48 h of MV. Although suctioning of secretions from the trachea to remove tracheobronchial and upper airway secretions is the standard of care, this method is ineffective for clearing peripheral airways and basal retained secretions.
The clinical practice guides referred to patients with respiratory muscles weakness like after prolonged MV and in neuromuscular diseases recommend the usage of cough augmentation and mucociliary clearance techniques in patients with CPF < 4.5 L/s (270 L'min) and using such techniques continuously in patients with CPF < 2.7 L/s (160 L/min). Cough augmentation techniques such as LVR are supposed to be used to reinforce cough effectiveness, particularly for patients with prolonged mechanical ventilation. So, the importance and strength of this study are to assess the effects of the LVR technique as a cough augmentation mean on CPF of post-extubated patients with an ineffective cough which can cause risky respiratory complications may lead to death in confronting to effects of traditional chest physiotherapy and suctioning and therefore, their therapy or management program can be precisely and appropriately planned. Moreover, the identification of effective, safe measures to optimize cough efficacy is, therefore, key to improving quality of life and minimizing morbidity & mortality rates in those patients. Additionally, as a secondary purpose to determine how much the LVR method, for augmenting CPF. is useful in enhancing the success of extubation and reducing the rate of re-intubation that indicated if extubation failure occurred.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt
- Faculty of Physical therapy Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Twenty-five patients who received traditional chest physiotherapy and LVR technique for 30-45 minutes for successive 4 Days after extubation
|
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
Other Names:
Positioning of the patient according the drainage position for each lobe of each lung and applying airway hygiene techniques such as percussion and vibration
|
Active Comparator: Control group
Twenty-five patients who received only traditional chest physiotherapy for 30 minutes at least for successive 4 Days after extubation
|
Positioning of the patient according the drainage position for each lobe of each lung and applying airway hygiene techniques such as percussion and vibration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough peak flow rate
Time Frame: "Day 4"
|
The maximum expiratory flow produced immediately after the glottis opens during a physiological cough
|
"Day 4"
|
Peak expiratory flow rate
Time Frame: "Day 4"
|
The maximum rate at which the air can be expired after a deep inspiration
|
"Day 4"
|
Oxygen Saturation
Time Frame: "Day 4"
|
The percentage that represents how haemoglobin are saturated with oxygen atoms
|
"Day 4"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extubation's success
Time Frame: "Day 4"
|
The patient pass first 48 - 72 hours after extubation alive and doesn't need to be reintubated
|
"Day 4"
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahmoud S. Ragab, Bsc, Cairo University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LVR in ICU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cough
-
Trevi TherapeuticsRecruitingRefractory Chronic CoughCanada, United Kingdom
-
Respivant Sciences GmbHRespivant Sciences Inc.TerminatedChronic Cough | IPF | Persistent Cough in IPFUnited States, United Kingdom, Netherlands, Australia, Belgium, New Zealand, Turkey, Italy, Germany, Czechia, Canada
-
The First Affiliated Hospital of Zhejiang Chinese...Completed
-
ILiAD BiotechnologiesCompletedPertussis/Whooping Cough | Bordetella Pertussis, Whooping CoughUnited Kingdom
-
KK Women's and Children's HospitalSingapore University of Technology and DesignUnknownCough | URTI | Cough Variant Asthma | Cough; Bronchial, With Grippe or InfluenzaSingapore
-
Shanghai Zhongshan HospitalNot yet recruitingSufentanil-induced Cough
-
Merck Sharp & Dohme LLCCompletedChronic CoughCanada, Czechia, Denmark, Hungary, Peru, Poland, Ukraine, United Kingdom, United States, Australia, China, Colombia, Germany, Guatemala, Israel, Italy, Malaysia, New Zealand, South Africa, Turkey
-
Khon Kaen UniversityCompleted
-
PhytoHealth CorporationCompleted
Clinical Trials on Lung volume recruitment technique
-
Ullevaal University HospitalWithdrawnSpinal Cord Injury | TetraplegiaNorway
-
Ottawa Hospital Research InstituteThe Ottawa HospitalUnknownMultiple SclerosisCanada
-
University of MinnesotaCompletedAmyotrophic Lateral SclerosisUnited States
-
University Hospital, LilleCompletedHemodynamic Monitoring | Fluid ChallengeFrance
-
Tanta UniversityRecruitingObesity, Morbid | Bariatric SurgeryEgypt
-
Children's Hospital of Eastern OntarioJesse's Journey-The Foundation for Gene and Cell TherapyCompletedDuchenne Muscular DystrophyCanada
-
CMC Ambroise ParéCompletedPneumonia | Pneumothorax | Respiratory Failure | Bleeding | Surgery--Complications | Cardiac Disease | AtelectasisFrance
-
Tanta UniversityRecruitingScoliosis; Adolescence | Postoperative Atelectasis | Lung RecruitmentEgypt
-
Hospital Privado de Comunidad de Mar del PlataRecruiting
-
Alexandria UniversityNot yet recruitingVentilator Lung | Echocardiography | Lung Recruitment | Chest Ultrasound | High Frequency VentilationEgypt