The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions

NCT02491762 | Unknown DMC

• 1 other identifier: CMC-15-0029-CTIL
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of breast reconstruction surgery on respiratory functions. 45 patients elected for unilateral or bilateral breast reconstruction surgery will go through respiratory function examinations a month prior to the surgery, one month after surgery and three months after surgery.

Conditions

Respiratory Function; Breast Reconstruction

Keywords

Serratus Anterior; Accessory Respiratory; Tissue Expander; Respiratory Function Tests

Outcome Measures

Primary Outcomes (24)

• Forced vital capacity -FVC

  Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort

  a month prior to surgery

• Forced expiratory volume at one second -FEV1

  Volume that has been exhaled at the end of the first second of forced expiration

  a month prior to surgery

• Maximum voluntary ventilation-MVV

  Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort

  a month prior to surgery

• Functional residual capacity-FRC

  Functional residual capacity: the volume in the lungs at the end-expiratory position

  a month prior to surgery

• Residual volume -RV

  Residual volume: the volume of air remaining in the lungs after a maximal exhalation.

  a month prior to surgery.

• Total lung capacity-TLC

  Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.

  a month prior to surgery.

• Maximal inspiratory pressure-MIP

  Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece

  a month prior to surgery.

• Maximal expiratory pressure-MEP

  Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.

  a month prior to surgery.

• Forced vital capacity -FVC

  Forced vital capacity: the determination of the vital capacity from a maximally forced

  a month after surgery

• Forced vital capacity -FVC

  Forced vital capacity: the determination of the vital capacity from a maximally forced

  three months after surgery

• Forced expiratory volume at one second -FEV1

  Volume that has been exhaled at the end of the first second of forced expiration

  a month after surgery

• Forced expiratory volume at one second -FEV1

  Volume that has been exhaled at the end of the first second of forced expiration

  three months after surgery

• Maximum voluntary ventilation-MVV

  Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort

  a month after surgery

• Maximum voluntary ventilation-MVV

  Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort

  three months after surgery

• Functional residual capacity-FRC

  Functional residual capacity: the volume in the lungs at the end-expiratory position

  a month after surgery

• Functional residual capacity-FRC

  Functional residual capacity: the volume in the lungs at the end-expiratory position

  three months after surgery

• Residual volume -RV

  Residual volume: the volume of air remaining in the lungs after a maximal exhalation.

  a month after surgery

• Residual volume -RV

  Residual volume: the volume of air remaining in the lungs after a maximal exhalation.

  three months after surgery

• Total lung capacity-TLC

  Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.

  a month after surgery.

• Total lung capacity-TLC

  Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.

  three months after surgery.

• Maximal inspiratory pressure-MIP

  Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece

  a month after surgery

• Maximal inspiratory pressure-MIP

  Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece

  three months after surgery.

• Maximal expiratory pressure-MEP

  Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.

  a month after surgery.

• Maximal expiratory pressure-MEP

  Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.

  three months after surgery.

Study Arms (2)

bilateral

bilateral breast construction candidates will go through respiratory function tests a month prior to surgery, a month after surgery and three months after surgery

Procedure: respiratory function tests

unilateral

unilateral breast construction candidates will go through respiratory function tests a month prior to surgery, a month after surgery and three months after surgery

Procedure: respiratory function tests

Interventions

respiratory function tests PROCEDURE

FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP

bilateral; unilateral

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients elected for breast reconstruction surgery using tissue expander-implant technique

You may qualify if:

• all subjects were elected for a unilateral or bilateral breast reconstruction using tissue expander by the Oncoplastic Committee of the plastic surgery unit in Carmel Medical Center.
• all subjects agrees to enroll in research

You may not qualify if:

• subject is in a mental or physical condition that does not allow her to go through respiratory function tests.
• subject was found with a respiratory disfunction or disease in the first respiratory function tests.

Sponsors & Collaborators

• Yaron Har-Shai: lead

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

Related Publications (22)

• Terakado S, Takeuchi T, Miura T, Sato H, Nishioka N, Fujieda Y, Kobayashi R, Ibukiyama C. Early occurrence of respiratory muscle deoxygenation assessed by near-infrared spectroscopy during leg exercise in patients with chronic heart failure. Jpn Circ J. 1999 Feb;63(2):97-103. doi: 10.1253/jcj.63.97.

  PMID: 10084371 BACKGROUND

• Legrand R, Marles A, Prieur F, Lazzari S, Blondel N, Mucci P. Related trends in locomotor and respiratory muscle oxygenation during exercise. Med Sci Sports Exerc. 2007 Jan;39(1):91-100. doi: 10.1249/01.mss.0000241638.90348.67.

  PMID: 17218889 BACKGROUND

• Legrand R, Prieur F, Marles A, Nourry C, Lazzari S, Blondel N, Mucci P. Respiratory muscle oxygenation kinetics: relationships with breathing pattern during exercise. Int J Sports Med. 2007 Feb;28(2):91-9. doi: 10.1055/s-2006-924056. Epub 2006 Jul 12.

  PMID: 16838222 BACKGROUND

• Lomax M, Tasker L, Bostanci O. An electromyographic evaluation of dual role breathing and upper body muscles in response to front crawl swimming. Scand J Med Sci Sports. 2015 Oct;25(5):e472-8. doi: 10.1111/sms.12354. Epub 2014 Dec 30.

  PMID: 25640018 BACKGROUND

• Machado de Sousa O, Costacurta L. Electromyographic study of the M. serratus anterior during respiration. Electromyogr Clin Neurophysiol. 1984 Nov-Dec;24(7):547-59. No abstract available.

  PMID: 6510353 BACKGROUND

• Mancini DM, Ferraro N, Nazzaro D, Chance B, Wilson JR. Respiratory muscle deoxygenation during exercise in patients with heart failure demonstrated with near-infrared spectroscopy. J Am Coll Cardiol. 1991 Aug;18(2):492-8. doi: 10.1016/0735-1097(91)90605-9.

  PMID: 1856417 BACKGROUND

• Matusiewicz AK, Carter AE, Landes RD, Yi R. Statistical equivalence and test-retest reliability of delay and probability discounting using real and hypothetical rewards. Behav Processes. 2013 Nov;100:116-22. doi: 10.1016/j.beproc.2013.07.019. Epub 2013 Aug 14.

  PMID: 23954833 BACKGROUND

• Moalla W, Dupont G, Berthoin S, Ahmaidi S. Respiratory muscle deoxygenation and ventilatory threshold assessments using near infrared spectroscopy in children. Int J Sports Med. 2005 Sep;26(7):576-82. doi: 10.1055/s-2004-830332.

  PMID: 16195992 BACKGROUND

• Ogata H, Arimitsu T, Matsuura R, Yunoki T, Horiuchi M, Yano T. Relationship between oxygenation in inactive biceps brachii muscle and hyperventilation during leg cycling. Physiol Res. 2007;56(1):57-65. doi: 10.33549/physiolres.930888. Epub 2006 Feb 23.

  PMID: 16497096 BACKGROUND

• Ogata H, Reyihan A, Yano T. Kinetics of oxygenation in inactive forearm muscle during ramp leg cycling. J Physiol Anthropol Appl Human Sci. 2004 Jan;23(1):7-17. doi: 10.2114/jpa.23.7.

  PMID: 14757996 BACKGROUND

• Reid DC, Bowden J, Lynne-Davies P. Role of selected muscles of respiration as influenced by posture and tidal volume. Chest. 1976 Nov;70(5):636-40. doi: 10.1378/chest.70.5.636.

  PMID: 975981 BACKGROUND

• TOKIZANE T, KAWAMATA K, TOKIZANE H. Electromyographic studies on the human respiratory muscles; studies on the activity pattern of neuromuscular units. Jpn J Physiol. 1952 Feb;2(3):232-47. doi: 10.2170/jjphysiol.2.232. No abstract available.

  PMID: 14927261 BACKGROUND

• Tsoi B, Ziolkowski NI, Thoma A, Campbell K, O'Reilly D, Goeree R. Systematic review on the patient-reported outcomes of tissue-expander/implant vs autologous abdominal tissue breast reconstruction in postmastectomy breast cancer patients. J Am Coll Surg. 2014 May;218(5):1038-48. doi: 10.1016/j.jamcollsurg.2014.02.011. Epub 2014 Feb 19. No abstract available.

  PMID: 24745568 BACKGROUND

• Wang L, Yoshikawa T, Hara T, Nakao H, Suzuki T, Fujimoto S. Which common NIRS variable reflects muscle estimated lactate threshold most closely? Appl Physiol Nutr Metab. 2006 Oct;31(5):612-20. doi: 10.1139/h06-069.

  PMID: 17111016 BACKGROUND

• Cannon DT, Grout SL, May CA, Strom SD, Wyckoff KG, Cipriani DJ, Buono MJ. Recruitment of the serratus anterior as an accessory muscle of ventilation during graded exercise. J Physiol Sci. 2007 Apr;57(2):127-31. doi: 10.2170/physiolsci.RP001807. Epub 2007 Apr 6.

  PMID: 17408533 BACKGROUND

• Cerqueira EP, Garbellini D. Electromyographic study of the pectoralis major, serratus anterior and external oblique muscles during respiratory activity in humans. Electromyogr Clin Neurophysiol. 1999 Apr-May;39(3):131-7.

  PMID: 10228878 BACKGROUND

• Chawla AK, Kachnic LA, Taghian AG, Niemierko A, Zapton DT, Powell SN. Radiotherapy and breast reconstruction: complications and cosmesis with TRAM versus tissue expander/implant. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):520-6. doi: 10.1016/s0360-3016(02)02951-6.

  PMID: 12243831 BACKGROUND

• Fischer JP, Wes AM, Nelson JA, Basta M, Rohrbach JI, Wu LC, Serletti JM, Kovach SJ. Propensity-matched, longitudinal outcomes analysis of complications and cost: comparing abdominal free flaps and implant-based breast reconstruction. J Am Coll Surg. 2014 Aug;219(2):303-12. doi: 10.1016/j.jamcollsurg.2014.02.028. Epub 2014 Apr 8.

  PMID: 24916480 BACKGROUND

• Gallistel CR. The importance of proving the null. Psychol Rev. 2009 Apr;116(2):439-53. doi: 10.1037/a0015251.

  PMID: 19348549 BACKGROUND

• GRONBAEK P, SKOUBY AP. The activity pattern of the diaphragm and some muscles of the neck and trunk in chronic asthmatics and normal controls. A comparative electromyographic study. Acta Med Scand. 1960 Dec 20;168:413-25. doi: 10.1111/j.0954-6820.1960.tb06672.x. No abstract available.

  PMID: 13708898 BACKGROUND

• JEFFERSON NC, OGAWA T, SYLEOS C, ZAMBETOGLOU A, NECHELES H. Restoration of respiration by nerve anastomosis. Am J Physiol. 1960 May;198:931-3. doi: 10.1152/ajplegacy.1960.198.5.931. No abstract available.

  PMID: 14407006 BACKGROUND

• Johnson BD, Babcock MA, Suman OE, Dempsey JA. Exercise-induced diaphragmatic fatigue in healthy humans. J Physiol. 1993 Jan;460:385-405. doi: 10.1113/jphysiol.1993.sp019477.

  PMID: 8487201 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

• Yaron Har-Shai, Proffesor

  Carmel Medical Center-Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaron Har-Shai, Proffesor

CONTACT

0507866206; yaron07@yahoo.com

Raviv Allon

CONTACT

0523460305; ravivallon@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor Yaron Har-Shai

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

IL (1)