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Morbid ObesityNCT02323009

Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

A study testing Esophageal Balloon and Cstat in people with Morbid Obesity, run by East Carolina University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome negative transpulmonary pressure; or adjusted by use of "CStat" to achieve the best effective static compliance will have any effect on outcomes with respect to ventilator weaning in tracheotomized morbidly obese patients… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Morbid Obesity
What is being tested?
Esophageal Balloon and Cstat
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jan 2011to Nov 2013
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Morbidly obese patients with BMI of 40 or greater
  • Ventilator dependent patients (defined as at least one prior failure at weaning)
  • Tracheotomized
  • No active underlying lung disease that would preclude ventilator weaning
  • Stable hemodynamics
  • Patient/ family able to give consent
Show all 9Show fewer
  • No naso-facial abnormalities that would interfere with placement of an esophageal balloon
  • Fio2 <= 60%
  • Patient able to tolerate Pressure Support ventilation

Who cannot join

  • Lack of consent
  • Patient deemed not weanable from mechanical ventilation as per the clinical judgement of the pulmonary physician
  • Significant lung, heart or neuromuscular disease that would interfere with or preclude ventilator weaning, including an active ongoing lung infection.
  • Contraindications to placement of an esophageal pressure monitoring device - such as ulcerations, tumors, diverticulitis, uncontrolled bleeding varices, sinusitis, epistaxis or recent nasopharyngeal surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vidant Medical Center

    Greenville, North Carolina, 27834

Other trials in United States

About this study

This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome negative transpulmonary pressure; or adjusted by use of "CStat" to achieve the best effective static compliance will have any effect on outcomes with respect to ventilator weaning in tracheotomized morbidly obese patients (BMI >=40) with at least one failed prior weaning attempt.

Read the detailed description

Tracheotomized morbidly obese patients (BMI >= 40) who had failed an initial attempt at ventilator weaning (defined in the investigators study as ventilator dependent) were randomly assigned to one of two methods for setting Positive End Expiratory Pressure (PEEP).

Patients randomized to the esophageal balloon arm (ESO group) had their PEEP adjusted to overcome negative transpulmonary pressure and maintain a positive transpulmonary pressure (Ptp) of 0 to 10 cm H20 - targeting as close to zero as possible.

Patients randomized to the static effective compliance arm (CStat group) had their PEEP adjusted to achieve the best static effective compliance as automatically calculated and displayed on the graphic interphase of the hamilton G5 or Galileo ventilator. For this group, the PEEP was adjusted in increments of 3 cm H20 until there was a less than 5% observed improvement in the static effective compliance. the PEEP with the best Cstat was chosen.

At the end of the intervention period, this intervention cohort (termed "PEEP intervention cohort") will be compared to a group of historical controls to compare the efficiency of a PEEP-based weaning protocol to traditional weaning methods.

The investigators hypothesized that PEEP levels titrated by use of an esophageal balloon to maintain a positive transpulmonary pressure between 0 to 10 cm H20, would lead to improved outcomes with respect to ventilator weaning in this subset of patients.

Conditions
Morbid Obesity
Being tested
Esophageal Balloon, Cstat
Keywords
Transpulmonary pressure, Esophageal balloon, Esophageal pressure monitoring device, Cstat, Static effective compliance, Ventilator weaning, Morbidly Obese Ventilator Dependent Tracheotomized Patients
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esophageal BalloonDevice

    Esophageal balloon was used to measure esophageal pressure (Paux) which was used as an estimate of pleural pressure. Transpulmonary pressure (Ptp) was calculated as the difference between airway pressure (Pao) and Paux. Applied PEEP was then adjusted to overcome negative Ptp which we maintained between 0 to 10 cm H20. All measurements were made at end-expiration.

  • CstatOther

    PEEP was adjusted to achieve the best CStat in this group of patients

Study groups in NCT02323009
Study groupRoleWhat they receive
Esophageal balloon ArmActive comparatorPatients in this arm were randomly assigned to have their PEEP adjusted to maintain a positive transpulmonary pressure (0 to 10 cm H20).
Receives: Device: Esophageal Balloon
Cstat ArmActive comparatorPatients in this arm had their PEEP adjusted to achieve the best static effective compliance (CStat).
Receives: Other: Cstat
Historic ControlsNo interventionThese were historic controls with similar patient characteristics weaned by traditional methods in the 2-year period prior to the start of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients weaned by day 30

    A patient was considered successfully weaned and "ventilator independent" if they were spontaneously breathing without ventilator support for at least 24 hours, and remained off the ventilator by day 30. If ventilator support was subsequently required, the patient was returned to their original group and considered not weaned. The patients were considered to be weaned or not, after a period of thirty days.

    Measured: 30-days

Secondary outcomes (1)

  1. Time to wean

    The time to wean/ time to achieve ventilator independence was measured from the date of randomization to the date of final successful liberation from mechanical ventilation. If patient had an unsuccessful initial wean, he was not considered weaned. Only patients who were considered weaned by day 30 accrued "time to ventilator independence."

    Measured: 30-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2014 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2013
  4. Study completionNov 2013

Why it stopped: Minimal recruitment. very few patients available with eligibility criteria

Resources

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
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02323009
Sponsor's protocol ID
Protocol 10-0343
Status last verified
Dec 2014
First submitted
12 Dec 2014
Last updated
23 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Talmor D, Sarge T, O'Donnell CR, Ritz R, Malhotra A, Lisbon A, Loring SH. Esophageal and transpulmonary pressures in acute respiratory failure. Crit Care Med. 2006 May;34(5):1389-94. doi: 10.1097/01.CCM.0000215515.49001.A2.

    PubMed 16540960

  • Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.

    PubMed 19001507

  • Talmor DS, Fessler HE. Are esophageal pressure measurements important in clinical decision-making in mechanically ventilated patients? Respir Care. 2010 Feb;55(2):162-72; discussion 172-4.

    PubMed 20105342

  • Loring SH, Pecchiari M, Della Valle P, Monaco A, Gentile G, D'Angelo E. Maintaining end-expiratory transpulmonary pressure prevents worsening of ventilator-induced lung injury caused by chest wall constriction in surfactant-depleted rats. Crit Care Med. 2010 Dec;38(12):2358-64. doi: 10.1097/CCM.0b013e3181fa02b8.

    PubMed 20890197

  • Loring SH, O'Donnell CR, Behazin N, Malhotra A, Sarge T, Ritz R, Novack V, Talmor D. Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010 Mar;108(3):515-22. doi: 10.1152/japplphysiol.00835.2009. Epub 2009 Dec 17.

    PubMed 20019160

  • Hedenstierna G. Esophageal pressure: benefit and limitations. Minerva Anestesiol. 2012 Aug;78(8):959-66. Epub 2012 Jun 14.

    PubMed 22699701

  • Owens RL, Campana LM, Hess L, Eckert DJ, Loring SH, Malhotra A. Sitting and supine esophageal pressures in overweight and obese subjects. Obesity (Silver Spring). 2012 Dec;20(12):2354-60. doi: 10.1038/oby.2012.120. Epub 2012 May 4.

    PubMed 22695479

  • MEAD J, GAENSLER EA. Esophageal and pleural pressures in man, upright and supine. J Appl Physiol. 1959 Jan;14(1):81-3. doi: 10.1152/jappl.1959.14.1.81. No abstract available.

    PubMed 13630830

  • Piraino T, Cook DJ. Optimal PEEP guided by esophageal balloon manometry. Respir Care. 2011 Apr;56(4):510-3. doi: 10.4187/respcare.00815. Epub 2011 Jan 21.

    PubMed 21255501

  • Washko GR, O'Donnell CR, Loring SH. Volume-related and volume-independent effects of posture on esophageal and transpulmonary pressures in healthy subjects. J Appl Physiol (1985). 2006 Mar;100(3):753-8. doi: 10.1152/japplphysiol.00697.2005. Epub 2005 Nov 23.

    PubMed 16306256

  • Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available.

    PubMed 24283226

  • 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 30245572

Questions about this trial

What is this clinical trial studying?

A study testing Esophageal Balloon and Cstat in people with Morbid Obesity, run by East Carolina University at 1 site 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 9 inclusion and 4 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 23 Dec 2014. 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 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?

The study was stopped early (reason given: Minimal recruitment. very few patients available with eligibility criteria). 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?

Number of patients weaned by day 30 (time frame: 30-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 NCT02323009, which also lists 12 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 23 Dec 2014.

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