Mechanical Power As a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients :Prospective Cohort Study.

November 29, 2024 updated by: Mohamed Mamdouh Moustafa, Assiut University
The primary objective is to evaluate the mechanical power as a predictor of weaning of mechanical ventilation in COPD patients hospitalized in the respiratory intensive care unit of Assiut University Hospital The secondary objective is to compare between mechanical power and diaphragmatic excursion (DE) assessed by ultrasound as a predictor of weaning in these patients. Also, to investigate the association between MP and DE and mortality in these patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD), a public health problem that is characterized by persistent airflow limitation ,it develops when there is a significant exposure of irritants causing an inflammatory response in the lungs, it is a common cause of respiratory failure which require hospital admission that is associated with increased medical costs.

The World Health Organization reported that COPD was the fifth most common disease globally in 2020, with a prevalence of 7.8-19.7% in adults. Approximately, 60% of patients with COPD admitted with hypercapnic respiratory failure.

Acute exacerbations of chronic obstructive pulmonary disease (COPD) is characterized by acute worsening of respiratory symptoms associated with the development of severe airflow limitation, gas trapping, dynamic hyperinflation and intrinsic positive end-expiratory pressure (PEEPi). In the most severe cases, these exacerbations may cause acute respiratory failure, which may require mechanical ventilation.

The process of weaning from mechanical ventilation remains one of the most critical challenges in patients underwent mechanical ventilation in the intensive care unit (ICU). The multidisciplinary team must study the optimal time for weaning from the mechanical ventilator as premature weaning may lead to weaning failure and thus increase the risk of hospital acquired infections, costs of care, length of ICU stay, Morbidity and Mortality.

Current guidelines recommend several indices applied at the bedside to predict successful weaning from mechanical ventilation. A spontaneous breathing trial (SBT) is an appropriate way to prepare the patient for extubation; however, even after successful SBT, failure rates and subsequent reintubation can exceed 20% in the highest-risk patient.

Mechanical power (MP) is the energy delivered by the ventilator to the entire respiratory system per time unit and combines all factors affecting the energy load of the respiratory system, including pressure, tidal volume, flow rate and respiratory rate.

MP is primarily calculated as the product of the applied airway pressure and minute ventilation and can be used as an estimate of the workload exerted on the respiratory muscles during spontaneous breathing.

MP is a major determinant to ensure adequate gas exchange in the body and a key factor in assessing the ability of a patient to successfully wean from mechanical ventilation.

Therefore, a larger scale clinical study is needed to further verify the relationship between MP and weaning outcomes in all critically ill mechanically ventilated patients.

Study Type

Observational

Enrollment (Estimated)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hoda A Makhlouf, Professor
  • Phone Number: 20 01001529442

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD patients who are mechanically ventilated in Respiratory ICU in Assiut University Hospital.

Description

Inclusion Criteria:

  • All COPD mechanically ventilated patients admitted to respiratory intensive care unit and eligible for weaning according to European respiratory society 2016 (5).

Exclusion Criteria:

- 1. Patients with associated lung pathology that may alter lung mechanics (Bronchiectasis, interstitial lung diseases, lung scarring) will be excluded from the study.

2. Tracheostomized patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paients with Successful weaning from Mechanical Ventilation
The criteria for successful extubation: successful extubation was defined as the ability to maintain spontaneous breathing for at least 48 h, without any ventilatory support.
Other: Chest ultrasound
to assess diaphragmatic excursion (DE(. M-mode was used to record the movement of the diaphragm during tidal breathing when the sampling line and diaphragm were as vertical as possible (not < 70°). The data was measured from the first respiratory cycle at 0 min after SBT.
Other: Calculation of Mechanical Power on the first day of intubation and before First trial of weaning:

Total respiratory rate (RR). Positive end-expiratory pressure (PEEP) (the external or applied PEEP) recorded, not the total PEEP, or intrinsic PEEP. The plateau pressure (Pplat) was measured during an inspiratory pause on the ventilator. Peak inspiratory pressure (Ppeak) should be obtained while the patient is relaxed, not coughing or moving in bed. MP was calculated according to Gattinoni's simplified mechanical power equation as follows (3,8):

MP(J/min)=0.098×VT×RR×(Ppeak-0.5×ΔP).
Patients with failed weaning from Mechanical Ventilation
failure extubation was defined as the reconnection to ventilator (invasive or noninvasive) within 48 h due to respiratory failure or other reasons. Extubation and the reconnection to ventilator were all based on SBT results and physicians' decision (5,9).
Other: Chest ultrasound
to assess diaphragmatic excursion (DE(. M-mode was used to record the movement of the diaphragm during tidal breathing when the sampling line and diaphragm were as vertical as possible (not < 70°). The data was measured from the first respiratory cycle at 0 min after SBT.
Other: Calculation of Mechanical Power on the first day of intubation and before First trial of weaning:

Total respiratory rate (RR). Positive end-expiratory pressure (PEEP) (the external or applied PEEP) recorded, not the total PEEP, or intrinsic PEEP. The plateau pressure (Pplat) was measured during an inspiratory pause on the ventilator. Peak inspiratory pressure (Ppeak) should be obtained while the patient is relaxed, not coughing or moving in bed. MP was calculated according to Gattinoni's simplified mechanical power equation as follows (3,8):

MP(J/min)=0.098×VT×RR×(Ppeak-0.5×ΔP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Evaluation the efficacy of MP as a predictor of weaning for COPD patients.
Time Frame: 2 years
Evaluation the efficacy of MP as a predictor of weaning for COPD patients.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-MP as a predictor of patient's mortality.
Time Frame: 2 years
MP as a predictor of patient's mortality.
2 years
2-MP and duration of hospital stay and ICU stay.
Time Frame: 2 years
MP and duration of hospital stay and ICU stay.
2 years
3-MP and ventilator induced lung injury.
Time Frame: 2 years
THE ASSOCIATION BETWEEN VALUE OF MP and ventilator induced lung injury.
2 years
4-Correlation analysis between mechanical power and other parameters of weaning: Respiratory rate, Rapid shallow breathing index, Heart Rate and Expiratory Tidal volume in evaluation of prognosis in COPD patients.
Time Frame: 2 years
Correlation analysis between mechanical power and other parameters of weaning: Respiratory rate, Rapid shallow breathing index, Heart Rate and Expiratory Tidal volume in evaluation of prognosis in COPD patients.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mechanical Power

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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