The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study. (EFFORT-1)

May 25, 2024 updated by: Phruet Soipetkasem, Ramathibodi Hospital
Over-assisted mechanical ventilation (MV) is linked to respiratory muscle disuse atrophy, while under-assisted MV can lead to patient self-inflicted lung injury (P-SILI) or respiratory muscle injuries. Both scenarios result in poor outcomes. This hypothesis aims to demonstrate the association between the degree of respiratory effort which was measured by P0.1, predicted Pmus, and predicted Δtranspulmonary pressure (ΔPL) with ventilator-free days (VFD) and 28-day mortality.

Study Overview

Status

Completed

Conditions

Detailed Description

Recently, the lung and diaphragm protective strategy is an important consideration when providing mechanical ventilation to critically ill patients. Although mechanical ventilation can be life-saving, improper management can cause harm. The harmful mechanical ventilator setting can result from over-assisted or under-assisted ventilation. Over-assisted ventilation can be caused by too much ventilatory support or calming down patients with high dosages of sedative drugs or muscle relaxants, which negatively affect the operation of the diaphragm leading to diaphragm muscle atrophy and weakness. This can make it more difficult to weaning and lead to prolonged use of mechanical ventilation. It appears that previous study found a correlation between percentage change in diaphragm thickness fraction, as measured by ultrasound, during the first week of mechanical ventilation and prolonged duration of mechanical ventilation, extended length of stay in the ICU, and complications. Additionally, in the study conclusions, a diaphragm thickness fraction of 15-30% during the first three days of mechanical ventilation was associated with the shortest duration of mechanical ventilation and this may potentially help guide the management of respiratory support.

On the other hand, the effect of under-assist breathing or allowing excessive respiratory effort could be harmful. Some reported in chronic obstructive pulmonary disease (COPD) exacerbation patients found that the increased negative intra-thoracic pressure potentially causes injury to the diaphragm sarcomeres, which are the muscle fibers responsible for generating force during breathing and it was proportional to the degree of obstruction. And compared light microscopy of the diaphragmatic muscles necropsy in patients who died of COPD with normal subjects. They found muscular necrosis and accumulation of fibrosis and collagen deposits. The cytoplasm was scattered, disrupted, and lipofuscin accumulation with hyper-eosinophilia was observed.

In addition, an excessive high respiratory effort can cause lung injury by patient-self known as patient self-inflicted lung injury (P-SILI), a theory first mentioned that the increased magnitude of negative intrathoracic pressure during inhalation may cause the fluid shift from the pulmonary capillaries to the alveoli causing pulmonary edema. This is relevant to the observational studies that the occurrence of negative intrathoracic pressure during large inhalations in obstruction airway patients, such as tracheal stenosis, also results in pulmonary edema. In latterly confirmed this hypothesis. Subsequent studies have supported this phenomenon and overall could be explained through the increase of transpulmonary pressure, pendelluft phenomenon and patient-ventilator asynchrony (PVA).

However, no current studies determine the relationship between respiratory effort measurement during mechanical ventilation and clinical outcomes. Therefore, we conduct the study to determine the relationship between respiratory effort parameters and clinical outcomes.

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

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

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Mr. Phruet Soipetkasem

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

A single-center analytical observational prospective study was conducted between June 2022 and April 2024. We enrolled acute respiratory failure patients who required mechanical ventilation from the intensive care units (ICUs) at Ramathibodi Hospital, Mahidol University.

Description

Inclusion Criteria:

  1. Participants must be aged between 18-75 years.
  2. Admitted to the critical care and semi-critical care units (ICUs) of the Department of -Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW).

  3. Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours:

    • PaO2/FiO2 greater than 150 or
    • PaO2 less than 60 mm Hg or
    • SaO2 less than 90 mm Hg or
    • Work of breathing more than 25 breaths per minute or requiring respiratory muscle assistance
  4. Permission obtained from the attending physician.
  5. Research participants or their direct relatives must sign informed consent.
  6. The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator.

Exclusion Criteria:

  1. Admitted to the hospital or had a history of hospital admission within a month before recruitment.
  2. History of cardiovascular or cerebrovascular events within the last 12 months.
  3. Pregnant.
  4. Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care.
  5. Active neurological or muscular disorders affecting stability.
  6. Brain coma, brain death, or status epilepticus.
  7. Severe mental health conditions, including active depression with psychotic features, bipolar disorder, or schizophrenia.
  8. Uncontrolled thyroid conditions within a month before recruitment.
  9. Uncorrectable patients with severe hypoxemia (P/F ratio less than 150).
  10. Patients receiving neuromuscular blocking agents.

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
Preference respiratory effort
The preference respiratory effort group was defined by either 1.5≤P0.1≤3.5 cmH2O, 5≤ predicted Pmus≤10 cmH2O, or predicted ΔPL≤20 cmH2O.
Insufficiency respiratory effort
The insufficiency respiratory effort group was defined by either P0.1<1.5 cmH2O or predicted Pmus < 5 cmH2O.
Excessive respiratory effort
The excessive respiratory effort group was defined by either P0.1 > 3.5 cmH2O, predicted Pmus > 10 cmH2O, or predicted ΔPL > 20 cmH2O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 days ventilator-free days (VFDs)
Time Frame: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.
The number of VFDs was defined as the number of days from the last day of mechanical ventilation to day 28. If a patient died during the first 28 days, their number of VFDs is equal to zero.
After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 days all-cause mortality
Time Frame: After intubated patients were recruited until alive or dead with in 28 days.
Short-term mortality was defined as death occurring within 28 days from the start of enrollment, documented as either alive or deceased 28 days after intubation.
After intubated patients were recruited until alive or dead with in 28 days.

Collaborators and Investigators

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

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Mr. Phruet Soipetkasem, Critical care doctor, Doctor of Critical care medicine Ramathibodi hospital
  • Study Chair: Pongdhep Theerawit, Assoc. Prof., Head of Critical care medicine Ramathibodi hospital
  • Study Director: Yuda Sutherasan, Assoc. Prof., Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital
  • Study Director: Mr. Detajin Junhasavasdikul, Asst.Prof., Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital

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 (Actual)

June 8, 2022

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

May 25, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA. MURA2022/317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Respiratory Distress Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe