Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

NCT02323009 | Terminated

• 1 other identifier: Protocol 10-0343
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 (BMI \>=40) with at least one failed prior weaning attempt.

Conditions

Morbid Obesity

Keywords

Transpulmonary pressure; Esophageal balloon; Esophageal pressure monitoring device; Cstat; Static effective compliance; Ventilator weaning; Morbidly Obese Ventilator Dependent Tracheotomized Patients

Outcome Measures

Primary Outcomes (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.

  30-days

Secondary Outcomes (1)

• Time to wean

  30-days

Study Arms (3)

Esophageal balloon Arm

ACTIVE COMPARATOR

Patients in this arm were randomly assigned to have their PEEP adjusted to maintain a positive transpulmonary pressure (0 to 10 cm H20).

Device: Esophageal Balloon

Cstat Arm

ACTIVE COMPARATOR

Patients in this arm had their PEEP adjusted to achieve the best static effective compliance (CStat).

Other: Cstat

Historic Controls

NO INTERVENTION

These were historic controls with similar patient characteristics weaned by traditional methods in the 2-year period prior to the start of the study.

Interventions

Esophageal Balloon DEVICE

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.

Esophageal balloon Arm

Cstat OTHER

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

Cstat Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No naso-facial abnormalities that would interfere with placement of an esophageal balloon
• Fio2 \<= 60%
• Patient able to tolerate Pressure Support ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Related Publications (12)

• 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.

  PMID: 16540960 BACKGROUND

• 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.

  PMID: 19001507 BACKGROUND

• 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.

  PMID: 20105342 BACKGROUND

• 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.

  PMID: 20890197 BACKGROUND

• 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.

  PMID: 20019160 BACKGROUND

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

  PMID: 22699701 BACKGROUND

• 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.

  PMID: 22695479 BACKGROUND

• 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.

  PMID: 13630830 BACKGROUND

• 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.

  PMID: 21255501 BACKGROUND

• 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.

  PMID: 16306256 BACKGROUND

• 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.

  PMID: 24283226 BACKGROUND

• 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.

  PMID: 30245572 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Shaw, MD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert Shaw, MD (Principal Investigator)

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

US (1)