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| ID | Type | Description | Link |
|---|---|---|---|
| COA No. MURA2023/642 | Other Identifier | Ramathibodi hospital |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After intubated patients were recruited until alive or dead with in 28 days. |
| 48 hours the pulmonary mechanics change |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pongdhep Theerawit, Assoc. Prof. | Critical care medicine Ramathibodi hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Critical care medicine Ramathibodi hospital, 270 Rama 6 Rd. Phayatai | Ratchathewi | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11719318 | Result | 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. | |
| 16387935 | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2023 | Jan 28, 2024 |
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The randomized control trial two arms by 1:1 ratio after the participants were recruited.
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|
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 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. | 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). | After intubated patients were recruited until 48 hours |
| 19869306 | 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. |
| 16694380 | 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. |
| 3057957 | 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. |
| 3230208 | 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. |
| 23263584 | 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. |
| 24199628 | 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. |
| 27626706 | 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. |
| 28930478 | 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. |
| 12421743 | 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. |
| 31915621 | 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. |
| 20225074 | 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. |
| 34115638 | 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. |
| 31694692 | 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. |
| 32204729 | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000097742 | Patient-Ventilator Asynchrony |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012131 | Respiratory Insufficiency |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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