Trial Outcomes & Findings for Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax (NCT NCT04630301)

Last Updated: 2025-10-20

Results Overview

Ppl is reported in centimeters of water (cmH2O). The normal pleural pressure (Ppl), the pressure within the space between the lung and chest wall, is typically subatmospheric, ranging from -3 to -5 cmH2O. This negative pressure is crucial for keeping the lungs inflated and facilitating normal breathing. In this study, all subjects have pneumothorax so will have abnormal Ppl greater than -3. Tension pneumothorax will have a positive Ppl. There is no known 'normal' or 'expected' value.

Recruitment status

COMPLETED

Target enrollment

37 participants

Primary outcome timeframe

Upon needle insertion into the pleural space and for 5 breath cycles, up to 60 seconds

Results posted on

2025-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Measurement of Pleural Pressure a. Patients admitted to the Johns Hopkins Hospital with spontaneous, iatrogenic, or tension pneumothorax referred to the Division of Interventional Pulmonology for thoracostomy will be recruited. Using standard sterile technique, a 14fr catheter will be inserted into the pleural space. An electronic manometer (Compass, Medline Industries, Inc.) will be connected in-line to the introducer needle and Ppl will be recorded for 3-5 respiratory cycles. After measurement, the manometer will be removed and the catheter will remain in place per routine standards of practice.
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pleural Manometry for the Characterization of Spontaneous and Tension Pneumothorax

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Measurement of Pleural Pressure n=37 Participants a. Patients admitted to the Johns Hopkins Hospital with spontaneous, iatrogenic, or tension pneumothorax referred to the Division of Interventional Pulmonology for thoracostomy will be recruited. Using standard sterile technique, a 14fr catheter will be inserted into the pleural space. An electronic manometer (Compass, Medline Industries, Inc.) will be connected in-line to the introducer needle and Ppl will be recorded for 3-5 respiratory cycles. After measurement, the manometer will be removed and the catheter will remain in place per routine standards of practice.
Age, Continuous	64.5 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Upon needle insertion into the pleural space and for 5 breath cycles, up to 60 seconds

Outcome measures

Outcome measures
Measure	Tension Participants n=9 Participants Tension group of pneumothorax subjects	Non-tension Participants n=28 Participants Non-Tension group of pneumothorax subjects
Pleural Pressure (Ppl) Prior to Evacuation of Pleural Air	7.44 cmH2O Standard Deviation 6.37	-1.79 cmH2O Standard Deviation 4.49

SECONDARY outcome

Timeframe: Up to 30 days

Population: Participants with data collected

Number of days that chest tube is in place.

Outcome measures

Outcome measures
Measure	Tension Participants n=33 Participants Tension group of pneumothorax subjects	Non-tension Participants Non-Tension group of pneumothorax subjects
Duration (Days) of Chest Tube Placement	4.30303 days Interval 0.0 to 27.0	—

SECONDARY outcome

Timeframe: Up to 30 days

Was the patient referred for pleurodesis (yes/no). Outcome value is for "yes" responses.

Outcome measures

Outcome measures
Measure	Tension Participants n=9 Participants Tension group of pneumothorax subjects	Non-tension Participants n=28 Participants Non-Tension group of pneumothorax subjects
Referral for Pleurodesis	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 30 days

Was the patient treated with an intrabronchial valve (yes/no). Outcome value is for "yes" responses.

Outcome measures

Outcome measures
Measure	Tension Participants n=37 Participants Tension group of pneumothorax subjects	Non-tension Participants Non-Tension group of pneumothorax subjects
Intrabronchial Valve (IBV) Placement	3 Participants	—

SECONDARY outcome

Timeframe: Up to 30 days

Was the patient referred for video assisted thoracoscopic surgery (yes/no). Outcome value is for "yes" responses.

Outcome measures

Outcome measures
Measure	Tension Participants n=37 Participants Tension group of pneumothorax subjects	Non-tension Participants Non-Tension group of pneumothorax subjects
Referral for Video Assisted Thoracoscopic Surgery (VATS)	1 Participants	—

Adverse Events

Measurement of Pleural Pressure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Thiboutot

Johns Hopkins University

Phone: 410-502-2533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place