Trial Outcomes & Findings for Safety of Optimal PEEP in NSICU Patients (NCT NCT03862027)

Results Overview

The Intracranial pressure (ICP) value after intervention will be considered equivalent to the ICP before intervention if the 95% upper bound of the change is lower than the non-inferiority margin of 4 mm Hg.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Within 5 minutes of catheter placement

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Esophageal Balloon Catheter All patients will have an esophageal balloon catheter 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 - 20 cm 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. Esophageal Balloon catheter: Pressures \[Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)\] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP"). Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esophageal Balloon Catheter n=1 Participants All patients will have an esophageal balloon catheter 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 - 20 cm 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. Esophageal Balloon catheter: Pressures \[Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)\] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP"). Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants
Region of Enrollment United States	1 Participants n=1 Participants

PRIMARY outcome

Timeframe: Within 5 minutes of catheter placement

The Intracranial pressure (ICP) value after intervention will be considered equivalent to the ICP before intervention if the 95% upper bound of the change is lower than the non-inferiority margin of 4 mm Hg.

Outcome measures

Outcome measures
Measure	Esophageal Balloon Catheter n=1 Participants All patients will have an esophageal balloon catheter 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 - 20 cm 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. Esophageal Balloon catheter: Pressures \[Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)\] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP"). Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.
Change in ICP Value	0 mm Hg Standard Deviation NA Standard Deviation not derived because n=1

SECONDARY outcome

Timeframe: Immediately before and 5 minutes after ventilator setting change

Cerebral perfusion pressure is equal to the mean arterial pressure (MAP) minus the intracranial pressure (ICP). The initial CPP is calculated by measuring CPP immediately before changing ventilator settings. The post-intervention CPP is measured 5 minutes after ventilator setting change is made. The difference between the initial CPP and the post-intervention CPP reflects the change in CPP.

Outcome measures

Outcome measures
Measure	Esophageal Balloon Catheter n=1 Participants All patients will have an esophageal balloon catheter 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 - 20 cm 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. Esophageal Balloon catheter: Pressures \[Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)\] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP"). Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.
Change in Cerebral Perfusion Pressure (CPP)	1 mm Hg Standard Deviation NA Standard Deviation not derived because n=1

SECONDARY outcome

Timeframe: Immediately before and 5 minutes after ventilator setting change

Mean Arterial Pressure (MAP) is the average arterial pressure in one cardiac cycle measured through an arterial line.

Outcome measures

Outcome measures
Measure	Esophageal Balloon Catheter n=1 Participants All patients will have an esophageal balloon catheter 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 - 20 cm 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. Esophageal Balloon catheter: Pressures \[Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)\] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP"). Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.
Change in Mean Arterial Pressure	1 mm Hg Standard Deviation NA Standard Deviation not derived because n=1

Adverse Events

Esophageal Balloon Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Kovacich, MD

University of North Carolina at Chapel Hill

Phone: 919-966-2532

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place