Comparison of Guiding Sedation Level by Respiratory Effort Versus Usual Care in Mechanically Ventilated Patients: A Randomized Controlled Trial (EFFORT-GUIDE Trial 2)

February 8, 2024 updated by: Phruet Soipetkasem, Ramathibodi Hospital
The objective of this research is to utilize respiratory effort parameters as a tool to assist in adjusting sedative drug levels for patients undergoing mechanical ventilation in the intensive care unit, in comparison to the conventional usual care approach.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The research investigators conduct daily screening for new participation in the intensive care unit and semi-intensive care unit, selecting individuals based on inclusion and exclusion criteria. In cases where patients require sedative drugs before the research investigators assessment, such as when patients are agitated or have difficulty asynchrony, standard sedative dosages are allowed in emergency rooms and the intensive care unit.

  • Informed consent for participation in the research is obtained from direct relatives of participants, accompanied by an explanation of the research procedures, methods, and potential complications. Relatives are required to sign the consent form as the primary decision-makers, considering the participants may be in an altered state of awareness and decision-making capacity.
  • Participants meeting the inclusion and exclusion criteria are registered for the research project and assigned a participant identification code. They are divided into two groups: one receiving the intervention involving the measurement of respiratory effort using P0.1 and Pocc then calculating to dynamic transpulmonary pressure swing (Predicted ΔPL) to adjust sedative drugs, and the other, serving as the control group, receives usual care adjustments made by the ward physicians' decision. The randomization process is facilitated by a third party.

The randomization involves creating equally distributed tokens for both groups (1:1 ratio), with the total number (n) representing the population to be included in the study. These tokens are placed in a random box for the randomization process. The basic information of research participants, laboratory, and mechanical ventilator parameters will be collected.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

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: Pongdhep Theerawit, Assoc. Prof.
  • Phone Number: +6622011629
  • Email: pongdhep@yahoo.com

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Critical care medicine Ramathibodi hospital, 270 Rama 6 Rd. Phayatai
        • Contact:
        • Contact:
        • Principal Investigator:
          • Phruet Soipetkasem, MD
        • Principal Investigator:
          • Vichapat Tharanon, MSc
        • Principal Investigator:
          • Krongtong Putthipokin, MSc
        • Principal Investigator:
          • Detajin Junhasavasdikul, Asst.Prof.
        • Principal Investigator:
          • Karuna chavalertsakul, MD
        • Principal Investigator:
          • Yuda Sutherasan, Assoc. Prof
        • Principal Investigator:
          • Sunthiti Morakul, Assoc. Prof

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

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.
  7. Indicate for receiving sedative drugs during an invasive mechanical ventilator include situations such as when the patient experiences pain or agitation after the placement of the breathing assistance device or when there is patient-ventilator asynchrony.

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. Allergic to sedative drugs used in the study.
  4. Pregnant.
  5. Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care.
  6. Active neurological or muscular disorders affecting stability.
  7. Brain coma, brain death, or status epilepticus.
  8. Severe mental health conditions, including active depression with psychotic features, bipolar disorder, or schizophrenia.
  9. Uncontrolled thyroid conditions within a month before recruitment.
  10. Uncorrectable patients with severe hypoxemia (P/F ratio less than 150).
  11. 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group: respiratory effort guide sedative dosage adjustment.
Following the enrollment of participants (acute respiratory failure requiring mechanical ventilation which sedation needed), the investigators proceeded to randomize participants into two groups: this intervention group, which employed the optimal respiratory effort parameters to guide the adjustment of sedative levels.
Other: The respiratory effort parameters guide sedative dosage.
The intervention involves the measurement of respiratory effort using P0.1 and Pocc then calculating to dynamic transpulmonary pressure swing (Predicted ΔPL) to adjust sedative drug dosage.
Other Names:
  • The respiratory effort parameters
No Intervention: Control group: usual care guide sedative dosage adjustment.
Following the enrollment of participants (acute respiratory failure requiring mechanical ventilation which sedation needed), the investigators proceeded to randomize participants into two groups: this control group, which employed usual care to guide the adjustment of sedative levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 days ventilator-free day
Time Frame: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.
To compare the number of ventilator-free days at 28 days between the method of measuring respiratory effort using the Dynamic Transpulmonary Pressure Swing (Predicted ΔPL) and P0.1, as opposed to usual care, for adjusting sedative drug dosages in patients with acute respiratory failure requiring mechanical ventilation.
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
The proper respiratory effort level during 48 hours
Time Frame: After intubated patients were recruited until 48 hours
To determine an appropriate level of respiratory effort and reduce excessive and inadequate effort factors by administering suitable sedative drugs to patients, minimizing lung injury from various causes, with the goal of facilitating the shortest possible duration of mechanical ventilation.
After intubated patients were recruited until 48 hours
28-day mortality rate
Time Frame: After intubated patients were recruited until alive or dead with in 28 days.
To compare 28-day mortality rate in patients adjusting sedative drug dosages using the Dynamic Transpulmonary Pressure Swing (Predicted ΔPL) and P0.1 methods compared to usual care.
After intubated patients were recruited until alive or dead with in 28 days.
48 hours the pulmonary mechanics change
Time Frame: After intubated patients were recruited until 48 hours
To investigate the pulmonary mechanics at 48 hours after sedative drug adjustment using the Dynamic Transpulmonary Pressure Swing (Predicted ΔPL) and P0.1 methods compared to usual care.
After intubated patients were recruited until 48 hours
The sedative dosage during 48 hours
Time Frame: After intubated patients were recruited until 48 hours
To compare the amount of sedative drugs administered to patients within 48 hours after intubation in the intervention group, adjusting drug dosages using the Dynamic Transpulmonary Pressure Swing (Predicted ΔPL) and P0.1 guidance, and the control group, adjusting drug dosages using Usual care guidance. The results will be presented separately for each type of drug, including Propofol infusion rate (mcg/kg/min), midazolam-equivalent infusion rate (mg/hc), fentanyl-equivalent infusion rate (mcg/hd), dexmedetomidine infusion rate (mcg/kg/h).
After intubated patients were recruited until 48 hours

Collaborators and Investigators

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

Sponsor

Ramathibodi Hospital

Investigators

  • Study Chair: Pongdhep Theerawit, Assoc. Prof., 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)

October 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFFORT-GUIDE trial 2
  • COA No. MURA2023/642 (Other Identifier: Ramathibodi hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The entire final data results will be shared when the research has been published after a trial period of 2 years.

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.

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