Obesity, MorbidPROP OPENNCT03951064
Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon
A study testing Esophageal balloon, Intervention Spontaneous Breathing Trial (SBT) and Extubation and Intervention Weaning after Tracheostomy in people with Obesity, Morbid and Ventilator-Induced Lung Injury, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Ventilator-Induced Lung Injury, Respiratory Failure
- What is being tested?
- Esophageal balloon, Intervention Spontaneous Breathing Trial (SBT) and Extubation and Intervention Weaning after Tracheostomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2021to 6 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Body mass index greater than or equal to 40
- Acute respiratory failure requiring mechanical ventilation
Who cannot join
- Refusal to give consent by the subject or their legally authorized representative
- Abdominal compartment syndrome
- Chest tube for pneumothorax
- Having been on a ventilator for >4 days
- Suspicion of or known intracranial hypertension
- Anticipated extubation within 24 hours
Show all 9Show fewer
- Chronic ventilator dependence
- Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)
- Incarceration
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator.
Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.
Read the detailed description
Study Design:
Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/fraction of inspired oxygen (FiO2) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm water (H2O).
- Being tested
- Esophageal balloon, Intervention Spontaneous Breathing Trial (SBT) and Extubation, Control Spontaneous Breathing Trial and Extubation, Intervention Weaning after Tracheostomy, Control Weaning after Tracheostomy
- Keywords
- Transpulmonary pressure, Esophageal balloon, Esophageal pressure monitoring, Mechanical ventilation
- Medical subject headings
- Obesity, Morbid, Ventilator-Induced Lung Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal balloonDevice
All patients in both groups will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into their nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.
Intervention Spontaneous Breathing Trial (SBT) and ExtubationProcedure or surgery
Patients in the Intervention group will undergo an SBT regardless of their PEEP level. The PEEP that generates a Ptp of 0 will be considered their optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP.
Control Spontaneous Breathing Trial and ExtubationProcedure or surgery
Patients in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking.
Intervention Weaning after TracheostomyProcedure or surgery
Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place patients in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a patient does not have an artificial airway.
Control Weaning after TracheostomyProcedure or surgery
The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Optimal PEEP | Experimental | The waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support). Receives: Device: Esophageal balloon; Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation; Procedure: Intervention Weaning after Tracheostomy |
| Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP | Active comparator | PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP. Receives: Device: Esophageal balloon; Procedure: Control Spontaneous Breathing Trial and Extubation; Procedure: Control Weaning after Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Ventilator-Free Days (VFD) by Day 28
The number of days a patient is alive and free from the ventilator up to day 28.
Measured: 28 days
Secondary outcomes (7)
Number of Participants Reintubated
Intubated within 72 hours of extubation
Measured: 72 hours after extubation
ICU Length of Stay
Number of days spent in the ICU
Measured: maximum duration of ICU stay, up to 46 days
Hospital Length of Stay
Number of days spent in the Hospital
Measured: maximum duration of hospital stay, up to 83 days
Number of Patients Receiving a Tracheostomy
Whether the patient required a tracheostomy to be liberated from the ventilator
Measured: during mechanical ventilation, up to 28 days
Number of Patients Extubated Early
Extubation prior to meeting established criteria (Control group only). Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking.
Measured: 28 days
Highest Richmond Agitation and Sedation Scale
Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the highest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome.
Measured: during mechanical ventilation, up to 28 days
Lowest Richmond Agitation and Sedation Scale
Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the lowest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome.
Measured: during mechanical ventilation, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start31 Mar 2021
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Why it stopped: Since November 2022, an indefinite pause of study activities caused by a hospital-wide shortage of esophageal balloons has persisted for almost a full year with an indefinite resupply date. Thus, the PI has opted to close to any further enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University
- Responsible party
- Sponsor
- Investigators
- Shannon Carson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951064
- Sponsor's protocol ID
- 18-2010
- Acronym
- PROP OPEN
- Status last verified
- Mar 2024
- First submitted
- 13 May 2019
- Last updated
- 5 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A deidentified dataset will be available to investigators 9-36 months following publication of the study.
Publications
Obi ON, Mazer M, Bangley C, Kassabo Z, Saadah K, Trainor W, Stephens K, Rice PL, Shaw R. Obesity and Weaning from Mechanical Ventilation-An Exploratory Study. Clin Med Insights Circ Respir Pulm Med. 2018 Sep 18;12:1179548418801004. doi: 10.1177/1179548418801004. eCollection 2018.
PubMed 30245572Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
PubMed 30776290
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03951064
- Acronym / sponsor ID
- PROP OPEN / 18-2010
- Keywords
- Transpulmonary pressure, Esophageal balloon, Esophageal pressure monitoring, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since November 2022, an indefinite pause of study activities caused by a hospital-wide shortage of esophageal balloons has persisted for almost a full year with an indefinite resupply date. Thus, the PI has opted to close to any further enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- East Carolina University
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 5 Jun 2024
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 research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator.
Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.
Detailed description
Study Design:
Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/fraction of inspired oxygen (FiO2) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm water (H2O).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal PEEP | Experimental | Device: Esophageal balloon, Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation, Procedure: Intervention Weaning after TracheostomyThe waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support). |
| Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP | Active comparator | Device: Esophageal balloon, Procedure: Control Spontaneous Breathing Trial and Extubation, Procedure: Control Weaning after TracheostomyPEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index greater than or equal to 40
- Acute respiratory failure requiring mechanical ventilation
Key exclusion criteria (9 listed)
- Refusal to give consent by the subject or their legally authorized representative
- Abdominal compartment syndrome
- Chest tube for pneumothorax
- Having been on a ventilator for >4 days
- Suspicion of or known intracranial hypertension
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 |
|---|---|---|
| Esophageal balloonAll patients in both groups will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into their nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape. | Device | Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP, Optimal PEEP |
| Intervention Spontaneous Breathing Trial (SBT) and ExtubationPatients in the Intervention group will undergo an SBT regardless of their PEEP level. The PEEP that generates a Ptp of 0 will be considered their optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP. | Procedure or surgery | Optimal PEEP |
| Control Spontaneous Breathing Trial and ExtubationPatients in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. | Procedure or surgery | Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP |
| Intervention Weaning after TracheostomyBased on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place patients in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a patient does not have an artificial airway. | Procedure or surgery | Optimal PEEP |
| Control Weaning after TracheostomyThe control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. | Procedure or surgery | Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP |
Primary outcome
Number of Ventilator-Free Days (VFD) by Day 28
Time frame: 28 days
The number of days a patient is alive and free from the ventilator up to day 28.
7 secondary outcomes
Number of Participants Reintubated
Time frame: 72 hours after extubation
ICU Length of Stay
Time frame: maximum duration of ICU stay, up to 46 days
Hospital Length of Stay
Time frame: maximum duration of hospital stay, up to 83 days
Number of Patients Receiving a Tracheostomy
Time frame: during mechanical ventilation, up to 28 days
Number of Patients Extubated Early
Time frame: 28 days
Highest Richmond Agitation and Sedation Scale
Time frame: during mechanical ventilation, up to 28 days
Lowest Richmond Agitation and Sedation Scale
Time frame: during mechanical ventilation, up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30245572Obi ON, Mazer M, Bangley C, Kassabo Z, Saadah K, Trainor W, Stephens K, Rice PL, Shaw R. Obesity and Weaning from Mechanical Ventilation-An Exploratory Study. Clin Med Insights Circ Respir Pulm Med. 2018 Sep 18;12:1179548418801004. doi: 10.1177/1179548418801004. eCollection 2018.
- Background: PubMed 30776290Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
- Individual participant dataSharing planned: Yes. A deidentified dataset will be available to investigators 9-36 months following publication of the study.
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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.
Shannon Carson, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal balloon, Intervention Spontaneous Breathing Trial (SBT) and Extubation and Intervention Weaning after Tracheostomy in people with Obesity, Morbid and Ventilator-Induced Lung Injury, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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 9 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: stopped early, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Ventilator-Free Days (VFD) by Day 28 (time frame: 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 NCT03951064, which also lists 2 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 2024.