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

NCT06433076 | Completed

• 1 other identifier: COA. MURA2022/317
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Effort; Respiratory Distress Syndrome; Lung Mechanics

Keywords

Respiratory effort; Acute respiratory distress syndrome (ARDS); Dynamic transpulmonary pressure swing (Predicted ΔPL); Patient self-inflicted lung injury (P-SILI); Patient ventilator asynchrony (PVA)

Outcome Measures

Primary Outcomes (1)

• 28 days ventilator-free days (VFDs)

  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 Outcomes (1)

• 28 days all-cause mortality

  After intubated patients were recruited until alive or dead with in 28 days.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants must be aged between 18-75 years.
• Admitted to the critical care and semi-critical care units (ICUs) of the Department of -Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW).
• 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
• Permission obtained from the attending physician.
• Research participants or their direct relatives must sign informed consent.
• The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator.

You may not qualify if:

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

Sponsors & Collaborators

• Ramathibodi Hospital: lead

Study Sites (1)

Mr. Phruet Soipetkasem

Bangkok, 10400, Thailand

Location

Related Publications (17)

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• Dzierba AL, Khalil AM, Derry KL, Madahar P, Beitler JR. Discordance Between Respiratory Drive and Sedation Depth in Critically Ill Patients Receiving Mechanical Ventilation. Crit Care Med. 2021 Dec 1;49(12):2090-2101. doi: 10.1097/CCM.0000000000005113.

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• Taran Z, Namadian M, Faghihzadeh S, Naghibi T. The Effect of Sedation Protocol Using Richmond Agitation-Sedation Scale (RASS) on Some Clinical Outcomes of Mechanically Ventilated Patients in Intensive Care Units: a Randomized Clinical Trial. J Caring Sci. 2019 Dec 1;8(4):199-206. doi: 10.15171/jcs.2019.028. eCollection 2019 Dec.

  PMID: 31915621 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mr. Phruet Soipetkasem, Critical care doctor

  Doctor of Critical care medicine Ramathibodi hospital

  PRINCIPAL INVESTIGATOR

• Pongdhep Theerawit, Assoc. Prof.

  Head of Critical care medicine Ramathibodi hospital

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical care medicine

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 29, 2024
• Study Start: June 8, 2022
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

TH (1)