Comparing the Effectiveness of Lung Expansion Therapy in Adult Human Subjects

NCT02892773 | Completed

• 1 other identifier: 19029
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to better understand how air is spread throughout study participants' lungs after abdominal surgery by comparing two lung inflation treatments:

1. 1.Incentive Spirometry (I.S.) lung expansion therapy
2. 2.EzPAP® lung expansion therapy.

Conditions

Atelectasis

Keywords

electrical impedance tomography; incentive spirometry; EzPAP; lung volume; atelectasis; positive airway pressure; pulmonary complication; abdominal surgery; end-expiratory lung volume

Outcome Measures

Primary Outcomes (1)

• Ventral and Dorsal end-expiratory lung impedance redistribution of ventilation

  EIT will be used to measure ventral and dorsal change in end-expiratory lung impedance before and after lung expansion therapy. Ventral and Dorsal lung impedance measurement is displayed on the EIT device as a percent (zero to 100). Investigators will record values into an electronic code book before and after lung expansion therapy. The difference between measured values will be used to quantify ventral and dorsal redistribution of ventilation. * Statistical analysis * An independent samples t-test or Mann-Whitney U test will be applied to determine if a statistically significant mean difference exists between groups. * Data will be reported as mean (SD) and 95% CI or median (IQR) depending upon normality of distribution. * Effect size = r (small effect \</= 0.1; medium effect = 0.3; Large effect \>/= 0.5 * Alpha set at ≤ 0.05 (two-tailed)

  Two years

Secondary Outcomes (1)

• Incidences of post-operative pulmonary complications

  Two years

Study Arms (2)

Incentive Spirometry Group

OTHER

* Participant will be asked to take 10 deep breaths through the mouthpiece of an incentive spirometer, followed by a 60 second pause. * This cycle will be repeated two more times. * A Respiratory Therapist will coach participants three times per day. * Each duration of Incentive Spirometry will last about 15 minutes.

Device: Incentive Spirometry

EzPAP® Positive Airway Pressure Group

ACTIVE COMPARATOR

* Participant will be coached by a Respiratory Therapist to breathe through the mouthpiece of an EzPAP® device for 10 breaths, followed by a 60 second pause. * This cycle will be repeated two more times. * The Respiratory Therapist will coach participants three times per day. * Each duration of EzPAP® therapy will last about 15 minutes.

Device: EzPAP® Positive Airway Pressure

Interventions

Incentive Spirometry DEVICE

A respiratory therapist will provide instruction on Incentive Spirometry (I.S.) procedure performance before supervised therapy and monitoring begins. * Study participants will be asked to take 10 deep breaths through the I.S.'s mouthpiece, followed by a 60 second pause. * The 10-breath cycle will be repeated 3 times per therapy session. * Each I.S. therapy session will last about 15 minutes, 3 times per day. * Lung monitoring and deep breathing measurements will occur during a scheduled I.S. sessions on day 1, 3, and 5 after surgery.

Incentive Spirometry Group

EzPAP® Positive Airway Pressure DEVICE

A respiratory therapist will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. * Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause. * The 10-breath cycle will be repeated 3 times. * Each EzPAP® therapy sessions will last about 15 minutes, 3 times per day. * Lung monitoring will occur during a scheduled EzPAP® sessions on day 1, 3, and 5 after surgery.

EzPAP® Positive Airway Pressure Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Human subjects 18 - 79 years of age
• Post-operative upper abdominal surgery
• Examples:
• Laparotomy
• Biliodigestive anastomosis
• Cholecystectomy
• Enterectomy
• Esophagectomy
• Gastrectomy
• Hepatectomy
• Pancreatectomy
• Unassisted spontaneous breathing
• Attending surgeon's approval
• Anticipated post-operative hospital length of stay greater than 3 days
• Documentation of written informed consent

You may not qualify if:

• Less than 18 or greater than 79 years of age
• Anticipated post-operative hospital length of stay less than 3 days
• Body mass index \> 50
• Excessive chest hair
• Inability to obtain written informed consent
• Inability to follow verbal instructions
• Pregnancy-self reported
• uncontrolled body movements
• Insertion of an artificial airway
• Hemodynamic instability
• Loss of skin integrity at site where EIT electrodes and belt are projected to come into contact (i.e., chest burns, open wounds/lesions, etc…).
• Chest tube or dressings that prohibit placement of EIT electrodes and belt
• Active implants (i.e., cardiac pacemaker, implantable cardioverter-defibrillator \[ICD\]), diaphragm pacer, or when device compatibility is in doubt.)
• Invasive or non-invasive mechanical ventilation support
• Unstable spinal lesions or fractures

Sponsors & Collaborators

• University of Virginia: lead
• Draeger Medical, Inc: collaborator

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

Related Publications (12)

• do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.

  PMID: 24510642 BACKGROUND

• Fagevik Olsen M, Wennberg E, Johnsson E, Josefson K, Lonroth H, Lundell L. Randomized clinical study of the prevention of pulmonary complications after thoracoabdominal resection by two different breathing techniques. Br J Surg. 2002 Oct;89(10):1228-34. doi: 10.1046/j.1365-2168.2002.02207.x.

  PMID: 12296888 BACKGROUND

• Garrard CS, Shah M. The effects of expiratory positive airway pressure on functional residual capacity in normal subjects. Crit Care Med. 1978 Sep-Oct;6(5):320-2. doi: 10.1097/00003246-197809000-00004.

  PMID: 363357 BACKGROUND

• Hinz J, Neumann P, Dudykevych T, Andersson LG, Wrigge H, Burchardi H, Hedenstierna G. Regional ventilation by electrical impedance tomography: a comparison with ventilation scintigraphy in pigs. Chest. 2003 Jul;124(1):314-22. doi: 10.1378/chest.124.1.314.

  PMID: 12853539 BACKGROUND

• Karsten J, Stueber T, Voigt N, Teschner E, Heinze H. Influence of different electrode belt positions on electrical impedance tomography imaging of regional ventilation: a prospective observational study. Crit Care. 2016 Jan 8;20:3. doi: 10.1186/s13054-015-1161-9.

  PMID: 26743570 BACKGROUND

• Lunardi AC, Paisani DM, Silva CCBMD, Cano DP, Tanaka C, Carvalho CRF. Comparison of lung expansion techniques on thoracoabdominal mechanics and incidence of pulmonary complications after upper abdominal surgery: a randomized and controlled trial. Chest. 2015 Oct;148(4):1003-1010. doi: 10.1378/chest.14-2696.

  PMID: 25973670 BACKGROUND

• Meier T, Luepschen H, Karsten J, Leibecke T, Grossherr M, Gehring H, Leonhardt S. Assessment of regional lung recruitment and derecruitment during a PEEP trial based on electrical impedance tomography. Intensive Care Med. 2008 Mar;34(3):543-50. doi: 10.1007/s00134-007-0786-9. Epub 2007 Jul 25.

  PMID: 17653529 BACKGROUND

• Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

  PMID: 26329355 BACKGROUND

• Riedel T, Richards T, Schibler A. The value of electrical impedance tomography in assessing the effect of body position and positive airway pressures on regional lung ventilation in spontaneously breathing subjects. Intensive Care Med. 2005 Nov;31(11):1522-8. doi: 10.1007/s00134-005-2734-x. Epub 2005 Sep 30.

  PMID: 16195908 BACKGROUND

• Stankiewicz-Rudnicki M, Gaszynski T, Gaszynski W. Assessment of regional ventilation in acute respiratory distress syndrome by electrical impedance tomography. Anaesthesiol Intensive Ther. 2015;47(1):77-81. doi: 10.5603/AIT.2015.0007.

  PMID: 25751294 BACKGROUND

• Westerdahl E, Lindmark B, Eriksson T, Friberg O, Hedenstierna G, Tenling A. Deep-breathing exercises reduce atelectasis and improve pulmonary function after coronary artery bypass surgery. Chest. 2005 Nov;128(5):3482-8. doi: 10.1378/chest.128.5.3482.

  PMID: 16304303 BACKGROUND

• Rowley DD, Malinowski TP, Di Peppe JL, Sharkey RM, Gochenour DU, Enfield KB. A Randomized Controlled Trial Comparing Two Lung Expansion Therapies After Upper Abdominal Surgery. Respir Care. 2019 Oct;64(10):1181-1192. doi: 10.4187/respcare.06812. Epub 2019 May 21.

  PMID: 31113857 DERIVED

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Daniel D Rowley, MSc RRT-ACCS

  Pulmonary Diagnostics & Respiratory Therapy Services, University of Virginia Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant and Care Provider will be masked from electrical impedance tomography distribution of ventilation recording during lung expansion therapy to reduce risk of performance bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc RRT-ACCS

Study Record Dates

• First Submitted: August 28, 2016
• First Posted: September 8, 2016
• Study Start: January 1, 2017
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)