Mechanical Ventilation ComplicationNCT05370248
The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient
A study testing Tidal volume 6 ml/kg and Tidal volume 10 ml/kg in people with Mechanical Ventilation Complication, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Tidal volume 6 ml/kg and Tidal volume 10 ml/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2021to Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age 18 years old
- Critically ill patients
Who cannot join
- Patient with ARDS (PaO2/FiO2 <200)
- Pregnant woman
- Patient with history of cardiac or thorax surgery 14 days prior to admission
- Patient with severe peripheral musculoskeletal conditions
- Patient with prolonged in-hospital stay (>2 weeks) in the last 3 months
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient: a Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Tidal volume 6 ml/kg, Tidal volume 10 ml/kg
- Keywords
- Mechanical ventilation, Diaphragm dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal volume 6 ml/kgOther
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.
Tidal volume 10 ml/kgOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The six | Experimental | The group who received tidal volume of 6 ml/kg from mechanical ventilation Receives: Other: Tidal volume 6 ml/kg |
| The ten | Active comparator | The group who received tidal volume of 10 ml/kg from mechanical ventilation Receives: Other: Tidal volume 10 ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
DD-24
Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.
Measured: 24 hours after mechanical ventilation
DD-48
Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.
Measured: 48 hours after mechanical ventilation
DD-72
Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.
Measured: 72 hours after mechanical ventilation
Secondary outcomes (3)
IL-6-24
Blook interleukin 6 24 hours after mechanical ventilation
Measured: 24 hours after mechanical ventilation
IL-6-48
Blook interleukin 6 48 hours after mechanical ventilation
Measured: 48 hours after mechanical ventilation
IL-6-72
Blook interleukin 6 72 hours after mechanical ventilation
Measured: 72 hours after mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Sep 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darma Putra Sitepu, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Dita Aditianingsih, Dr, Study chair, Dr Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370248
- Sponsor's protocol ID
- DPS1
- Status last verified
- May 2022
- First submitted
- 28 Apr 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared since it is belong to the hospital and patient did not consent it to be published.
Publications
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.
PubMed 26271686Tremblay 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.
PubMed 16231069Brochard 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.
PubMed 27626833Petrof 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.
PubMed 30144420Supinski 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.
PubMed 28887062Demoule 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.
PubMed 23641946Zambon 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.
PubMed 27620292Moxham J, Goldstone J. Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61.
PubMed 7875282
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05370248
- Acronym / sponsor ID
- DPS1
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Mechanical ventilation, Diaphragm dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 11 May 2022 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The six | Experimental | Other: Tidal volume 6 ml/kgThe group who received tidal volume of 6 ml/kg from mechanical ventilation |
| The ten | Active comparator | Other: Tidal volume 10 ml/kgThe group who received tidal volume of 10 ml/kg from mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Minimum age 18 years old
- Critically ill patients
Key exclusion criteria (5 listed)
- Patient with ARDS (PaO2/FiO2 <200)
- Pregnant woman
- Patient with history of cardiac or thorax surgery 14 days prior to admission
- Patient with severe peripheral musculoskeletal conditions
- Patient with prolonged in-hospital stay (>2 weeks) in the last 3 months
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 |
|---|---|---|
| Tidal volume 6 ml/kgTidal 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. | Other | The six |
| Tidal volume 10 ml/kgTidal 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. | Other | The ten |
Primary outcome
DD-24
Time frame: 24 hours after mechanical ventilation
Diaphragm dysfunction 24 hours after mechanical ventilation assessed by ultrasound.
DD-48
Time frame: 48 hours after mechanical ventilation
Diaphragm dysfunction 48 hours after mechanical ventilation assessed by ultrasound.
DD-72
Time frame: 72 hours after mechanical ventilation
Diaphragm dysfunction 72 hours after mechanical ventilation assessed by ultrasound.
3 secondary outcomes
IL-6-24
Time frame: 24 hours after mechanical ventilation
IL-6-48
Time frame: 48 hours after mechanical ventilation
IL-6-72
Time frame: 72 hours after mechanical ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 26271686Mehta 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.
- Background: PubMed 16231069Tremblay 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.
- Background: PubMed 27626833Brochard 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.
- Background: PubMed 30144420Petrof 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.
- Background: PubMed 28887062Supinski 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.
- Background: PubMed 23641946Demoule 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.
- Background: PubMed 27620292Zambon 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.
- Background: PubMed 7875282Moxham J, Goldstone J. Assessment of respiratory muscle strength in the intensive care unit. Eur Respir J. 1994 Nov;7(11):2057-61.
- Individual participant dataSharing planned: No. IPD will not be shared since it is belong to the hospital and patient did not consent it to be published.
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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.
Dita Aditianingsih, Dr study chair
Dr Cipto Mangunkusumo 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 Tidal volume 6 ml/kg and Tidal volume 10 ml/kg in people with Mechanical Ventilation Complication, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 May 2022. 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 Indonesia. 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?
Results are not available in the source record.
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?
DD-24 (time frame: 24 hours after mechanical ventilation). The study lists 3 primary outcomes in all. 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 NCT05370248, which also lists 8 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 11 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.