Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized clinical trial to measure the effect of tidal volume (group 6 ml/kg vs 10 ml/kg) on diaphragm dysfunction on mechanically ventilated critical patient.
Patient was enrolled in the first day receiving mechanical ventilation in ICU. Patient was included to group A or group B. Group A patient will receive tidal volume of 6 ml/kg and group B patient will receive tidal volume of 10 ml/kg. The assignment was randomized. Followed for 3 days. After 24, 48, and 72 hours, patient blood will be collected to measure the interleukin value, and diaphragm dysfunction will be observed by the use of ultrasonography by expert doctor from radiology department. Data will be analyzed statistically if there is an effect of tidal volume difference on diaphragm dysfunction and interleukin-6 as marker of inflammation. The minimal sample of patient is 44 patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The six | Experimental | The group who received tidal volume of 6 ml/kg from mechanical ventilation |
|
| The ten | Active Comparator | The group who received tidal volume of 10 ml/kg from mechanical ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tidal volume 6 ml/kg | Other | Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DD-24 | Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound. | 24 hours after mechanical ventilation |
| DD-48 | Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound. | 48 hours after mechanical ventilation |
| DD-72 | Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound. | 72 hours after mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6-24 | Blook interleukin 6 24 hours after mechanical ventilation | 24 hours after mechanical ventilation |
| IL-6-48 | Blook interleukin 6 48 hours after mechanical ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge outcome | The outcome at hospital discharge (alive or death) | Up to three months after mechanical ventilation |
| LOS in hospital | Length of stay (days) in hospital |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dita Aditianingsih, Dr | Dr Cipto Mangunkusumo Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Cipto Mangunkusumo Hospital | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26271686 | Background | Mehta AB, Syeda SN, Wiener RS, Walkey AJ. Epidemiological trends in invasive mechanical ventilation in the United States: A population-based study. J Crit Care. 2015 Dec;30(6):1217-21. doi: 10.1016/j.jcrc.2015.07.007. Epub 2015 Jul 16. | |
| 16231069 | Background | Tremblay LN, Slutsky AS. Ventilator-induced lung injury: from the bench to the bedside. Intensive Care Med. 2006 Jan;32(1):24-33. doi: 10.1007/s00134-005-2817-8. Epub 2005 Oct 18. No abstract available. |
Not provided
Not provided
IPD will not be shared since it is belong to the hospital and patient did not consent it to be published.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013990 | Tidal Volume |
| ID | Term |
|---|---|
| D007320 | Inspiratory Capacity |
| D014797 | Vital Capacity |
| D014109 | Total Lung Capacity |
| D008176 | Lung Volume Measurements |
Not provided
Not provided
Patient was divided into group A and B. Group A received tidal volume of 6 ml/kg and group B received tidal volume of 10 ml/kg.
Not provided
Not provided
Participants are blinded to which group they belong and they have given consent to that.
The person assigning patients to each group is the research assistant. The person setting the mechanical ventilator is the anesthesiology resident. The person assessing outcome with ultrasound is radiology department staff, who does not know which group the patient belong.
The person assessing outcome of interleukin is laboratory personnel, who does not know which group the patient belong.
The person collecting and freezing data into worksheet is the research assistant.
The person analyzing final data is the primary investigator.
| Tidal volume 10 ml/kg | Other | Tidal volume is defined as the amount of air that moves in or out of the lungs with each respiratory cycle, given by the mechanical ventilator. |
|
| 48 hours after mechanical ventilation |
| IL-6-72 | Blook interleukin 6 72 hours after mechanical ventilation | 72 hours after mechanical ventilation |
| Up to three months after mechanical ventilation |
| LOS in ICU | Length of stay (days) in ICU | Up to three months after mechanical ventilation |
| Weaning failure | The condition where patient failed for spontaneous breathing trial after mechanical ventilation. Grouped into success/failed. | Up to three months after mechanical ventilation |
| Intubation time | Time (hours) long when a patient was intubated | At extubation after mechanical ventilation |
| 27626833 | Background | Brochard L, Slutsky A, Pesenti A. Mechanical Ventilation to Minimize Progression of Lung Injury in Acute Respiratory Failure. Am J Respir Crit Care Med. 2017 Feb 15;195(4):438-442. doi: 10.1164/rccm.201605-1081CP. |
| 30144420 | Background | Petrof BJ. Diaphragm Weakness in the Critically Ill: Basic Mechanisms Reveal Therapeutic Opportunities. Chest. 2018 Dec;154(6):1395-1403. doi: 10.1016/j.chest.2018.08.1028. Epub 2018 Aug 23. |
| 28887062 | Background | Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5. |
| 23641946 | Background | Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC. |
| 27620292 | Background | Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12. |
| 7875282 | Background | Moxham J, Goldstone J. Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61. |
| D012129 |
| Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |