Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

Respiratory Failure Clinical Trial

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Official title:

Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03951064
• Other study ID #: 18-2010
• Status: Terminated
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: December 6, 2022

Study information

• Verified date: March 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body mass index greater than or equal to 40

• Acute respiratory failure requiring mechanical ventilation

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Lung Injury
• Obesity, Morbid
• Respiratory Failure
• Respiratory Insufficiency
• Ventilator-Induced Lung Injury

Intervention

Device:
• Esophageal balloon
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.

Procedure:
• Intervention Spontaneous Breathing Trial (SBT) and Extubation
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 Extubation
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 Tracheostomy
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 Tracheostomy
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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	East Carolina University	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	East Carolina University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Beitler 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days
Secondary	Number of Participants Reintubated	Intubated within 72 hours of extubation	72 hours after extubation
Secondary	ICU Length of Stay	Number of days spent in the ICU	maximum duration of ICU stay, up to 46 days
Secondary	Hospital Length of Stay	Number of days spent in the Hospital	maximum duration of hospital stay, up to 83 days
Secondary	Number of Patients Receiving a Tracheostomy	Whether the patient required a tracheostomy to be liberated from the ventilator	during mechanical ventilation, up to 28 days
Secondary	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.	28 days
Secondary	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.	during mechanical ventilation, up to 28 days
Secondary	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.	during mechanical ventilation, up to 28 days