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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02491762
Other study ID # CMC-15-0029-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 16, 2015
Last updated July 13, 2015
Start date August 2015
Est. completion date August 2017

Study information

Verified date July 2015
Source Carmel Medical Center
Contact Yaron Har-Shai, Proffesor
Phone 0507866206
Email yaron07@yahoo.com
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial 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.


Description:

Breast reconstruction surgery using tissue expander and implant technique is the most common breast reconstruction surgery. During this procedure, the surgeon will insert a silicone expander under the Pectoralis Major muscle. In order to fully cover the expander, the surgeon will detach the Serratus Anterior [SA] muscle from its natural attachments in the rib cage and will attach the free edges to the lateral edge of the Pectoralis Major muscle. After the wound is healed, a gradual inflation of the expander with a physiological fluid will be done by injecting the fluid into a subcutaneous filling port connected to the expander by silicone tubing. When the tissues around the expander will reach the required size, the tissue expander can be replaced by a permanent silicone implant.

The SA attachments are to the superior angle, medial border and inferior angle of the scapula and to the first to eighth ribs. Its main functions are stabilization and protraction of the scapula and turning the glenoid cavity superiorly in abduction of arms. In addition, the SA is an accessory respiratory muscle: when the scapula is stabilized, its contraction will lift the rib cage in order to help breathing. The importance of the SA in breathing has been examined since the late 19th century and until this day it is not fully agreed upon. Most studies agree that the SA major role in breathing is in deep breaths and is that the muscle is most effective for this purpose when arms are lifted.

Since breast reconstruction procedure includes detachment of the SA from the rib cage and there by canceling its respiratory function, an examination of the respiratory functions before and after the procedure is in order to determine whether or not the overall respiratory functions had been effected.

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. The examinations will include the following tests: Spirometry: FVC, FEV1, MVV. Lung capacities: FRC, RV, TLC. Breathing muscle strength: MIP, MEP.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
respiratory function tests
FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP

Locations

Country Name City State
Israel Carmel Medical Center Haifa

Sponsors (1)

Lead Sponsor Collaborator
Yaron Har-Shai

Country where clinical trial is conducted

Israel, 

References & Publications (22)

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. Epub 2007 Apr 6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

JEFFERSON NC, OGAWA T, SYLEOS C, ZAMBETOGLOU A, NECHELES H. Restoration of respiration by nerve anastomosis. Am J Physiol. 1960 May;198:931-3. — View Citation

Johnson BD, Babcock MA, Suman OE, Dempsey JA. Exercise-induced diaphragmatic fatigue in healthy humans. J Physiol. 1993 Jan;460:385-405. — View Citation

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. — View Citation

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. Epub 2006 Jul 12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Feb 23. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Forced vital capacity -FVC Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort a month prior to surgery No
Primary 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 No
Primary Maximum voluntary ventilation-MVV Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort a month prior to surgery No
Primary Functional residual capacity-FRC Functional residual capacity: the volume in the lungs at the end-expiratory position a month prior to surgery No
Primary Residual volume -RV Residual volume: the volume of air remaining in the lungs after a maximal exhalation. a month prior to surgery. No
Primary 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. No
Primary 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. No
Primary 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. No
Primary Forced vital capacity -FVC Forced vital capacity: the determination of the vital capacity from a maximally forced a month after surgery No
Primary Forced vital capacity -FVC Forced vital capacity: the determination of the vital capacity from a maximally forced three months after surgery No
Primary 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 No
Primary 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 No
Primary Maximum voluntary ventilation-MVV Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort a month after surgery No
Primary Maximum voluntary ventilation-MVV Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort three months after surgery No
Primary Functional residual capacity-FRC Functional residual capacity: the volume in the lungs at the end-expiratory position a month after surgery No
Primary Functional residual capacity-FRC Functional residual capacity: the volume in the lungs at the end-expiratory position three months after surgery No
Primary Residual volume -RV Residual volume: the volume of air remaining in the lungs after a maximal exhalation. a month after surgery No
Primary Residual volume -RV Residual volume: the volume of air remaining in the lungs after a maximal exhalation. three months after surgery No
Primary 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. No
Primary 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. No
Primary 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 No
Primary 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. No
Primary 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. No
Primary 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. No
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