AdultNCT03698799
Adherence to LPV in SICU and Associated Clinical Outcomes
An observational study of Adult and Guideline Adherence, run by Mahidol University at 1 site in Thailand.
Trial summary
Lung Protective Ventilation strategy (LPV) with low tidal volume and adequate positive end-expiratory pressure is recommended for not only patients with acute respiratory distress syndrome (ARDS) but also those without ARDS too. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult, Guideline Adherence, Humans
- How many people
- 306 participants
- Where
- 1 siteThailand
- Study dates
- 9 Apr 2018to 20 Mar 2020
- Phase
- Observational
- 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
Study population: All patients whose age of 18 years old or more admitted to two participating SICU and requiring MV support, either at SICU admission or during stay in SICU, via either endotracheal or tracheostomy tube with the anticipated duration of 12 hours or more without exclusion criteria are included.
Who may be able to join
- Patients whose age of 18 years old or more
- Patients admitted to two participating SICU
- Patients requiring MV support with the anticipated duration of 12 hours or more
Who cannot join
- Patients not requiring MV support during SICU stay
- Patients requiring MV support for less than 12 hours in SICU
- Patients requiring MV support for more than 24 hours prior to SICU admission
- Patients included in this study once and re-admitted to the SICU
- Patients requiring non-invasive MV support
- Moribund or terminal cases
- Patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence Rate to Lung Protective Mechanical Ventilation in Patients Admitted to Surgical Intensive Care Units and Associated Clinical Outcomes
Lung Protective Ventilation strategy (LPV) with low tidal volume and adequate positive end-expiratory pressure is recommended for not only patients with acute respiratory distress syndrome (ARDS) but also those without ARDS too. From previous studies, adherence to LPV strategy reported is only 40% and data is limited in surgical patients. The investigators aim to describe ventilation management and find out the adherence rate to LPV strategy applied to surgical patients admitted to the surgical intensive care unit (SICU) and their associated outcomes.
Read the detailed description
Mechanical ventilation (MV) is one of the one organ support most frequently applied to patients admitted to intensive care units (ICUs). Despite considering as a life-saving intervention, MV may have detrimental effects, namely ventilator-induced lung injury (VILI). A mechanical breath with positive airway pressure may overstretch alveoli, especially in the non-dependent part of the lungs, and subsequently result in barotrauma and volutrauma. While cyclic opening and closing of alveoli during mechanical breath due to alveolar collapse at the end of expiration can cause atelec-trauma or cyclic atelectasis. All of these can lead to the activation of respiratory and systemic inflammatory response, so-called bio-trauma. To minimize the effects of MV on VILI, the lung protective mechanical ventilation (LPV) strategy have been proposed and now generally accepted as a standard practice in mechanically ventilated patients. The LPV strategy basically consists of ventilation with the low tidal volume of 6-8 mL/kg of predicted body weight (PBW) with limited plateau pressure of less than 30 cm H2O plus applying sufficient amount of positive end-expiratory pressure (PEEP) to prevent atelectasis. The LPV strategy has been clearly demonstrated benefits in not only patients with acute respiratory distress syndrome (ARDS) but also those with normal lungs including lessened respiratory and systemic inflammatory response and injured lungs, decreased duration of MV and length of stay (LOS), improved organ failure, and decreased pulmonary and other complications as well as mortality. Nevertheless, the adherence rate to the LPV strategy reported in the literatures is only approximately 40% in mechanically ventilated patients. For surgical patients, approximately 65% of those admitted to ICU require MV support either following operation or during their stay in ICU. To date, there is limited data regarding MV management in surgical patients who required MV support perioperatively. In addition, the difference in perioperative MV practices and their associated clinical outcomes has been not well determined in this setting. The aim of this study is to explore the current practice of MV according to the LPV strategy applied to surgical patients admitted to surgical ICU (SICU) and their associated clinical outcome. The primary outcome of this study is to determine the adherence rate to the LPV strategy at the initiation of MV support in mechanically ventilated patients in SICU. The LPV strategy in this study is defined as ventilation with the tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm of water. The secondary outcomes are factors associated with the adherence to the LPV strategy, incidences of pulmonary and other complications, LOS in SICU and in hospital, SICU and hospital discharge status, and status at 28 and 90 days following the initiation of MV support. Patients are divided into two groups, LPV and Non-LPV, according to their MV setting and clinical outcomes are statistically compared between groups.
- Conditions
- Adult, Guideline Adherence, Humans, Intensive Care Units, Perioperative/Postoperative Complications, Respiration, Artificial
- Keywords
- Adherence, Intensive Care Unit, Lung Protective Strategy, Mechanical Ventilation, Perioperative Critical Care, Surgical
- Medical subject headings
- Postoperative Complications, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LPV | Patients receive LPV strategy at the initiation of MV support. The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O. | |
| Non-LPV | Patients do not receive LPV strategy at the initiation of MV support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate to LPV strategy at the initiation of MV support
The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O.
Measured: During the first 24 hours following the initiation of MV support
Secondary outcomes (3)
Incidences of pulmonary and other complications
Pulmonary complications include pneumonia, ARDS, atelectasis, restoration of MV support after liberation from MV, pleural effusion, cardiogenic pulmonary edema, pneumothorax and new pulmonary infiltration. Other complications include stroke, myocardial ischemia/infarction, arrhythmias, acute kidney injury, sepsis, new infection other than pneumonia, and re-admission to the SICU.
Measured: During the first 7 consecutive days following the initiation of MV support
Length of stay in SICU and in hospital
Total days of stay in SICU and in hospital following the initiation of MV support.
Measured: Up to 90 days following the initiation of MV support
SICU and hospital discharge status, and status at 28 and 90 days
Status whether alive or decease
Measured: Up to 90 days following the initiation of MV support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start9 Apr 2018
- Primary completion30 Jun 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AdultStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annop Piriyapatsom, MD, Mahidol University
- Investigators
- Annop Piriyapatsom, MD, Principal investigator, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698799
- Sponsor's protocol ID
- 077/2561(EC4)
- Status last verified
- Jun 2020
- First submitted
- 27 Sep 2018
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sutherasan Y, Vargas M, Pelosi P. Protective mechanical ventilation in the non-injured lung: review and meta-analysis. Crit Care. 2014 Mar 18;18(2):211. doi: 10.1186/cc13778. No abstract available.
PubMed 24762100Biehl M, Kashiouris MG, Gajic O. Ventilator-induced lung injury: minimizing its impact in patients with or at risk for ARDS. Respir Care. 2013 Jun;58(6):927-37. doi: 10.4187/respcare.02347.
PubMed 23709192Terragni P, Ranieri VM, Brazzi L. Novel approaches to minimize ventilator-induced lung injury. Curr Opin Crit Care. 2015 Feb;21(1):20-5. doi: 10.1097/MCC.0000000000000172.
PubMed 25546532Petrucci N, De Feo C. Lung protective ventilation strategy for the acute respiratory distress syndrome. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD003844. doi: 10.1002/14651858.CD003844.pub4.
PubMed 23450544Wang C, Wang X, Chi C, Guo L, Guo L, Zhao N, Wang W, Pi X, Sun B, Lian A, Shi J, Li E. Lung ventilation strategies for acute respiratory distress syndrome: a systematic review and network meta-analysis. Sci Rep. 2016 Mar 9;6:22855. doi: 10.1038/srep22855.
PubMed 26955891Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
PubMed 23093163Neto AS, Simonis FD, Barbas CS, Biehl M, Determann RM, Elmer J, Friedman G, Gajic O, Goldstein JN, Linko R, Pinheiro de Oliveira R, Sundar S, Talmor D, Wolthuis EK, Gama de Abreu M, Pelosi P, Schultz MJ; PROtective Ventilation Network Investigators. Lung-Protective Ventilation With Low Tidal Volumes and the Occurrence of Pulmonary Complications in Patients Without Acute Respiratory Distress Syndrome: A Systematic Review and Individual Patient Data Analysis. Crit Care Med. 2015 Oct;43(10):2155-63. doi: 10.1097/CCM.0000000000001189.
PubMed 26181219Santamaria JD, Tobin AE, Reid DA. Do we practise low tidal-volume ventilation in the intensive care unit? a 14-year audit. Crit Care Resusc. 2015 Jun;17(2):108-12.
PubMed 26017128Kalhan R, Mikkelsen M, Dedhiya P, Christie J, Gaughan C, Lanken PN, Finkel B, Gallop R, Fuchs BD. Underuse of lung protective ventilation: analysis of potential factors to explain physician behavior. Crit Care Med. 2006 Feb;34(2):300-6. doi: 10.1097/01.ccm.0000198328.83571.4a.
PubMed 16424706Umoh NJ, Fan E, Mendez-Tellez PA, Sevransky JE, Dennison CR, Shanholtz C, Pronovost PJ, Needham DM. Patient and intensive care unit organizational factors associated with low tidal volume ventilation in acute lung injury. Crit Care Med. 2008 May;36(5):1463-8. doi: 10.1097/CCM.0b013e31816fc3d0.
PubMed 18434907Chen YF, Lim CK, Ruan SY, Jerng JS, Lin JW, Kuo PH, Wu HD, Yu CJ. Factors associated with adherence to low-tidal volume strategy for acute lung injury and acute respiratory distress syndrome and their impacts on outcomes: an observational study and propensity analysis. Minerva Anestesiol. 2014 Nov;80(11):1158-68. Epub 2014 Feb 25.
PubMed 24569355
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Rate to Lung Protective Mechanical Ventilation in Patients Admitted to Surgical Intensive Care Units and Associated Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03698799
- Acronym / sponsor ID
- 077/2561(EC4)
- Conditions
- Adult, Guideline Adherence, Humans, Intensive Care Units, Perioperative/Postoperative Complications, Respiration, Artificial
- Keywords
- Adherence, Intensive Care Unit, Lung Protective Strategy, Mechanical Ventilation, Perioperative Critical Care, Surgical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 9 Oct 2018 (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.
Lung Protective Ventilation strategy (LPV) with low tidal volume and adequate positive end-expiratory pressure is recommended for not only patients with acute respiratory distress syndrome (ARDS) but also those without ARDS too. From previous studies, adherence to LPV strategy reported is only 40% and data is limited in surgical patients. The investigators aim to describe ventilation management and find out the adherence rate to LPV strategy applied to surgical patients admitted to the surgical intensive care unit (SICU) and their associated outcomes.
Detailed description
Mechanical ventilation (MV) is one of the one organ support most frequently applied to patients admitted to intensive care units (ICUs). Despite considering as a life-saving intervention, MV may have detrimental effects, namely ventilator-induced lung injury (VILI). A mechanical breath with positive airway pressure may overstretch alveoli, especially in the non-dependent part of the lungs, and subsequently result in barotrauma and volutrauma. While cyclic opening and closing of alveoli during mechanical breath due to alveolar collapse at the end of expiration can cause atelec-trauma or cyclic atelectasis. All of these can lead to the activation of respiratory and systemic inflammatory response, so-called bio-trauma. To minimize the effects of MV on VILI, the lung protective mechanical ventilation (LPV) strategy have been proposed and now generally accepted as a standard practice in mechanically ventilated patients. The LPV strategy basically consists of ventilation with the low tidal volume of 6-8 mL/kg of predicted body weight (PBW) with limited plateau pressure of less than 30 cm H2O plus applying sufficient amount of positive end-expiratory pressure (PEEP) to prevent atelectasis. The LPV strategy has been clearly demonstrated benefits in not only patients with acute respiratory distress syndrome (ARDS) but also those with normal lungs including lessened respiratory and systemic inflammatory response and injured lungs, decreased duration of MV and length of stay (LOS), improved organ failure, and decreased pulmonary and other complications as well as mortality. Nevertheless, the adherence rate to the LPV strategy reported in the literatures is only approximately 40% in mechanically ventilated patients. For surgical patients, approximately 65% of those admitted to ICU require MV support either following operation or during their stay in ICU. To date, there is limited data regarding MV management in surgical patients who required MV support perioperatively. In addition, the difference in perioperative MV practices and their associated clinical outcomes has been not well determined in this setting. The aim of this study is to explore the current practice of MV according to the LPV strategy applied to surgical patients admitted to surgical ICU (SICU) and their associated clinical outcome. The primary outcome of this study is to determine the adherence rate to the LPV strategy at the initiation of MV support in mechanically ventilated patients in SICU. The LPV strategy in this study is defined as ventilation with the tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm of water. The secondary outcomes are factors associated with the adherence to the LPV strategy, incidences of pulmonary and other complications, LOS in SICU and in hospital, SICU and hospital discharge status, and status at 28 and 90 days following the initiation of MV support. Patients are divided into two groups, LPV and Non-LPV, according to their MV setting and clinical outcomes are statistically compared between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPV | – | –Patients receive LPV strategy at the initiation of MV support. The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O. |
| Non-LPV | – | –Patients do not receive LPV strategy at the initiation of MV support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients whose age of 18 years old or more admitted to two participating SICU and requiring MV support, either at SICU admission or during stay in SICU, via either endotracheal or tracheostomy tube with the anticipated duration of 12 hours or more without exclusion criteria are included.
Key inclusion criteria (3 listed)
- Patients whose age of 18 years old or more
- Patients admitted to two participating SICU
- Patients requiring MV support with the anticipated duration of 12 hours or more
Key exclusion criteria (7 listed)
- Patients not requiring MV support during SICU stay
- Patients requiring MV support for less than 12 hours in SICU
- Patients requiring MV support for more than 24 hours prior to SICU admission
- Patients included in this study once and re-admitted to the SICU
- Patients requiring non-invasive MV support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence rate to LPV strategy at the initiation of MV support
Time frame: During the first 24 hours following the initiation of MV support
The LPV strategy is defined as ventilation with tidal volume of <8 mL/kg of PBW plus applying PEEP of at least 5 cm H2O.
3 secondary outcomes
Incidences of pulmonary and other complications
Time frame: During the first 7 consecutive days following the initiation of MV support
Length of stay in SICU and in hospital
Time frame: Up to 90 days following the initiation of MV support
SICU and hospital discharge status, and status at 28 and 90 days
Time frame: Up to 90 days following the initiation of MV support
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 5 Jun 2020.
- Background: PubMed 24762100Sutherasan Y, Vargas M, Pelosi P. Protective mechanical ventilation in the non-injured lung: review and meta-analysis. Crit Care. 2014 Mar 18;18(2):211. doi: 10.1186/cc13778. No abstract available.
- Background: PubMed 23709192Biehl M, Kashiouris MG, Gajic O. Ventilator-induced lung injury: minimizing its impact in patients with or at risk for ARDS. Respir Care. 2013 Jun;58(6):927-37. doi: 10.4187/respcare.02347.
- Background: PubMed 25546532Terragni P, Ranieri VM, Brazzi L. Novel approaches to minimize ventilator-induced lung injury. Curr Opin Crit Care. 2015 Feb;21(1):20-5. doi: 10.1097/MCC.0000000000000172.
- Background: PubMed 23450544Petrucci N, De Feo C. Lung protective ventilation strategy for the acute respiratory distress syndrome. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD003844. doi: 10.1002/14651858.CD003844.pub4.
- Background: PubMed 26955891Wang C, Wang X, Chi C, Guo L, Guo L, Zhao N, Wang W, Pi X, Sun B, Lian A, Shi J, Li E. Lung ventilation strategies for acute respiratory distress syndrome: a systematic review and network meta-analysis. Sci Rep. 2016 Mar 9;6:22855. doi: 10.1038/srep22855.
- Background: PubMed 23093163Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
- Background: PubMed 26181219Neto AS, Simonis FD, Barbas CS, Biehl M, Determann RM, Elmer J, Friedman G, Gajic O, Goldstein JN, Linko R, Pinheiro de Oliveira R, Sundar S, Talmor D, Wolthuis EK, Gama de Abreu M, Pelosi P, Schultz MJ; PROtective Ventilation Network Investigators. Lung-Protective Ventilation With Low Tidal Volumes and the Occurrence of Pulmonary Complications in Patients Without Acute Respiratory Distress Syndrome: A Systematic Review and Individual Patient Data Analysis. Crit Care Med. 2015 Oct;43(10):2155-63. doi: 10.1097/CCM.0000000000001189.
- Results publication: PubMed 26017128Santamaria JD, Tobin AE, Reid DA. Do we practise low tidal-volume ventilation in the intensive care unit? a 14-year audit. Crit Care Resusc. 2015 Jun;17(2):108-12.
- Results publication: PubMed 16424706Kalhan R, Mikkelsen M, Dedhiya P, Christie J, Gaughan C, Lanken PN, Finkel B, Gallop R, Fuchs BD. Underuse of lung protective ventilation: analysis of potential factors to explain physician behavior. Crit Care Med. 2006 Feb;34(2):300-6. doi: 10.1097/01.ccm.0000198328.83571.4a.
- Results publication: PubMed 18434907Umoh NJ, Fan E, Mendez-Tellez PA, Sevransky JE, Dennison CR, Shanholtz C, Pronovost PJ, Needham DM. Patient and intensive care unit organizational factors associated with low tidal volume ventilation in acute lung injury. Crit Care Med. 2008 May;36(5):1463-8. doi: 10.1097/CCM.0b013e31816fc3d0.
- Results publication: PubMed 24569355Chen YF, Lim CK, Ruan SY, Jerng JS, Lin JW, Kuo PH, Wu HD, Yu CJ. Factors associated with adherence to low-tidal volume strategy for acute lung injury and acute respiratory distress syndrome and their impacts on outcomes: an observational study and propensity analysis. Minerva Anestesiol. 2014 Nov;80(11):1158-68. Epub 2014 Feb 25.
- Individual participant dataSharing planned: No
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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.
Annop Piriyapatsom, MD principal investigator
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult and Guideline Adherence, run by Mahidol University 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 3 inclusion and 7 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 5 Jun 2020. 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?
Adherence rate to LPV strategy at the initiation of MV support (time frame: During the first 24 hours following the initiation of MV support). 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 NCT03698799, which also lists 11 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 5 Jun 2020.