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

NCT06242236 | Completed DMC

• 2 other identifiers: EFFORT-GUIDE trial 2COA No. MURA2023/642
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ARDS; Respiratory Effort; Mechanical Ventilation Complication; Sedation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 28 days ventilator-free day

  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 Outcomes (4)

• 28-day mortality rate

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

• 48 hours the pulmonary mechanics change

  After intubated patients were recruited until 48 hours

• The proper respiratory effort level during 48 hours

  After intubated patients were recruited until 48 hours

• The sedative dosage during 48 hours

  After intubated patients were recruited until 48 hours

Study Arms (2)

Intervention group: respiratory effort guide sedative dosage adjustment.

ACTIVE COMPARATOR

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.

Control group: usual care guide sedative dosage adjustment.

NO INTERVENTION

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.

Interventions

The respiratory effort parameters guide sedative dosage. OTHER

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.

Also known as: The respiratory effort parameters

Intervention group: respiratory effort guide sedative dosage adjustment.

Eligibility Criteria

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

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.
• 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.

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.
• Allergic to sedative drugs used in the study.
• 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)

Critical care medicine Ramathibodi hospital, 270 Rama 6 Rd. Phayatai

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (16)

• Orozco-Levi M, Lloreta J, Minguella J, Serrano S, Broquetas JM, Gea J. Injury of the human diaphragm associated with exertion and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1734-9. doi: 10.1164/ajrccm.164.9.2011150.

  PMID: 11719318 RESULT

• Scott A, Wang X, Road JD, Reid WD. Increased injury and intramuscular collagen of the diaphragm in COPD: autopsy observations. Eur Respir J. 2006 Jan;27(1):51-9. doi: 10.1183/09031936.06.00143004.

  PMID: 16387935 RESULT

• Moore RL, Binger CA. THE RESPONSE TO RESPIRATORY RESISTANCE : A COMPARISON OF THE EFFECTS PRODUCED BY PARTIAL OBSTRUCTION IN THE INSPIRATORY AND EXPIRATORY PHASES OF RESPIRATION. J Exp Med. 1927 May 31;45(6):1065-80. doi: 10.1084/jem.45.6.1065.

  PMID: 19869306 RESULT

• Barach AL, Eckman M. THE EFFECTS OF INHALATION OF HELIUM MIXED WITH OXYGEN ON THE MECHANICS OF RESPIRATION. J Clin Invest. 1936 Jan;15(1):47-61. doi: 10.1172/JCI100758. No abstract available.

  PMID: 16694380 RESULT

• Dreyfuss D, Soler P, Basset G, Saumon G. High inflation pressure pulmonary edema. Respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis. 1988 May;137(5):1159-64. doi: 10.1164/ajrccm/137.5.1159.

  PMID: 3057957 RESULT

• Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.

  PMID: 3230208 RESULT

• Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.

  PMID: 23263584 RESULT

• Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.

  PMID: 24199628 RESULT

• Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.

  PMID: 27626706 RESULT

• Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.

  PMID: 28930478 RESULT

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

  PMID: 12421743 RESULT

• 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

• Karamchandani K, Rewari V, Trikha A, Batra RK. Bispectral index correlates well with Richmond agitation sedation scale in mechanically ventilated critically ill patients. J Anesth. 2010 Jun;24(3):394-8. doi: 10.1007/s00540-010-0915-4. Epub 2010 Mar 12.

  PMID: 20225074 RESULT

• 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.

  PMID: 34115638 RESULT

• Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.

  PMID: 31694692 RESULT

• Bertoni M, Spadaro S, Goligher EC. Monitoring Patient Respiratory Effort During Mechanical Ventilation: Lung and Diaphragm-Protective Ventilation. Crit Care. 2020 Mar 24;24(1):106. doi: 10.1186/s13054-020-2777-y.

  PMID: 32204729 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

• Pongdhep Theerawit, Assoc. Prof.

  Critical care medicine Ramathibodi hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical care medicine

Model Details: The randomized control trial two arms by 1:1 ratio after the participants were recruited.

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)