ARDSNCT06242236
Comparison of Guiding Sedation Level by Respiratory Effort Versus Usual Care in Mechanically Ventilated Patients: A Randomized Controlled Trial (EFFORT-GUIDE Trial 2)
A study testing The respiratory effort parameters guide sedative dosage. in people with ARDS and Respiratory Effort, run by Ramathibodi Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ARDS, Respiratory Effort, Mechanical Ventilation Complication
- What is being tested?
- The respiratory effort parameters guide sedative dosage.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Critical care medicine Ramathibodi hospital, 270 Rama 6 Rd. Phayatai
Ratchathewi, Bangkok, 10400
About this study
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.
Read the 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.
- Being tested
- The respiratory effort parameters guide sedative dosage.
- 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
- Medical subject headings
- Respiratory Distress Syndrome, Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The respiratory effort parameters guide sedative dosage.Other
Also called The respiratory effort parameters
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.
Secondary outcomes (4)
28-day mortality rate
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.
Measured: After intubated patients were recruited until alive or dead with in 28 days.
48 hours the pulmonary mechanics change
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.
Measured: After intubated patients were recruited until 48 hours
The proper respiratory effort level during 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.
Measured: After intubated patients were recruited until 48 hours
The sedative dosage during 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).
Measured: After intubated patients were recruited until 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Oct 2023
- Primary completion31 Oct 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized control trial two arms by 1:1 ratio after the participants were recruited.
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phruet Soipetkasem, Ramathibodi Hospital
- Investigators
- Pongdhep Theerawit, Assoc. Prof., Study chair, Critical care medicine Ramathibodi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242236
- Sponsor's protocol ID
- EFFORT-GUIDE trial 2
- Other IDs
- COA No. MURA2023/642
- Status last verified
- Jul 2025
- First submitted
- 28 Jan 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The entire final data results will be shared when the research has been published after a trial period of 2 years.
Publications
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.
PubMed 11719318Scott 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.
PubMed 16387935Moore 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.
PubMed 19869306Barach 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.
PubMed 16694380Dreyfuss 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.
PubMed 3057957Mascheroni 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.
PubMed 3230208Yoshida 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.
PubMed 23263584Yoshida 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.
PubMed 24199628Beduneau 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.
PubMed 27626706Goligher 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.
PubMed 28930478Sessler 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.
PubMed 12421743Taran 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.
PubMed 31915621Karamchandani 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.
PubMed 20225074Dzierba 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.
PubMed 34115638Bertoni 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.
PubMed 31694692
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Guiding Sedation Level by Respiratory Effort Versus Usual Care in Mechanically Ventilated Patients: A Randomized Controlled Trial (EFFORT-GUIDE Trial 2)
- ClinicalTrials.gov ID
- NCT06242236
- Acronym / sponsor ID
- EFFORT-GUIDE trial 2
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomized control trial two arms by 1:1 ratio after the participants were recruited.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: respiratory effort guide sedative dosage adjustment. | Active comparator | Other: The respiratory effort parameters guide sedative dosage.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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Permission obtained from the attending physician.
- Research participants or their direct relatives must sign informed consent.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The respiratory effort parameters guide sedative dosage.Also: The respiratory effort parametersThe 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 | Intervention group: respiratory effort guide sedative dosage adjustment. |
Primary outcome
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.
4 secondary outcomes
28-day mortality rate
Time frame: 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
The proper respiratory effort level during 48 hours
Time frame: After intubated patients were recruited until 48 hours
The sedative dosage during 48 hours
Time frame: After intubated patients were recruited until 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Results publication: PubMed 11719318Orozco-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.
- Results publication: PubMed 16387935Scott 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.
- Results publication: PubMed 19869306Moore 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.
- Results publication: PubMed 16694380Barach 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.
- Results publication: PubMed 3057957Dreyfuss 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.
- Results publication: PubMed 3230208Mascheroni 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.
- Results publication: PubMed 23263584Yoshida 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.
- Results publication: PubMed 24199628Yoshida 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.
- Results publication: PubMed 27626706Beduneau 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.
- Results publication: PubMed 28930478Goligher 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.
- Results publication: PubMed 12421743Sessler 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.
- Results publication: PubMed 31915621Taran 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.
- Individual participant dataSharing planned: No. The entire final data results will be shared when the research has been published after a trial period of 2 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pongdhep Theerawit, Assoc. Prof. study chair
Critical care medicine Ramathibodi hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The respiratory effort parameters guide sedative dosage. in people with ARDS and Respiratory Effort, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 days ventilator-free day (time frame: After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242236, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.