Respiratory FunctionNCT02491762
The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions
An observational study of Respiratory Function and Breast Reconstruction, run by Yaron Har-Shai at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function, Breast Reconstruction
- What is being tested?
- respiratory function tests
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients elected for breast reconstruction surgery using tissue expander-implant technique
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Respiratory Function, Breast Reconstruction
- Being tested
- respiratory function tests
- Keywords
- Serratus Anterior, Accessory Respiratory, Tissue Expander, Respiratory Function Tests
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory function testsProcedure or surgery
FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: respiratory function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity -FVC
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
Measured: 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
Measured: a month prior to surgery
Maximum voluntary ventilation-MVV
Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort
Measured: a month prior to surgery
Functional residual capacity-FRC
Functional residual capacity: the volume in the lungs at the end-expiratory position
Measured: a month prior to surgery
Residual volume -RV
Residual volume: the volume of air remaining in the lungs after a maximal exhalation.
Measured: 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.
Measured: 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
Measured: 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.
Measured: a month prior to surgery.
Forced vital capacity -FVC
Forced vital capacity: the determination of the vital capacity from a maximally forced
Measured: a month after surgery
Forced vital capacity -FVC
Forced vital capacity: the determination of the vital capacity from a maximally forced
Measured: 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
Measured: 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
Measured: three months after surgery
Maximum voluntary ventilation-MVV
Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort
Measured: a month after surgery
Maximum voluntary ventilation-MVV
Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort
Measured: three months after surgery
Functional residual capacity-FRC
Functional residual capacity: the volume in the lungs at the end-expiratory position
Measured: a month after surgery
Functional residual capacity-FRC
Functional residual capacity: the volume in the lungs at the end-expiratory position
Measured: three months after surgery
Residual volume -RV
Residual volume: the volume of air remaining in the lungs after a maximal exhalation.
Measured: a month after surgery
Residual volume -RV
Residual volume: the volume of air remaining in the lungs after a maximal exhalation.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: three months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Respiratory FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaron Har-Shai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaron Har-Shai, Carmel Medical Center
- Investigators
- Yaron Har-Shai, Proffesor, Principal investigator, Carmel Medical Center-Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491762
- Sponsor's protocol ID
- CMC-15-0029-CTIL
- Status last verified
- Jul 2015
- First submitted
- 16 Jun 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10084371Legrand 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.
PubMed 17218889Legrand 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.
PubMed 16838222Lomax 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.
PubMed 25640018Machado 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.
PubMed 6510353Mancini 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.
PubMed 1856417Matusiewicz 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.
PubMed 23954833Moalla 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.
PubMed 16195992Ogata 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.
PubMed 16497096Ogata 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.
PubMed 14757996Reid 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.
PubMed 975981TOKIZANE 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.
PubMed 14927261Tsoi 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.
PubMed 24745568Wang 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.
PubMed 17111016Cannon 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.
PubMed 17408533
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions
- ClinicalTrials.gov ID
- NCT02491762
- Acronym / sponsor ID
- CMC-15-0029-CTIL
- Conditions
- Respiratory Function, Breast Reconstruction
- Keywords
- Serratus Anterior, Accessory Respiratory, Tissue Expander, Respiratory Function Tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Yaron Har-ShaiUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral | – | Procedure: respiratory function testsbilateral breast construction candidates will go through respiratory function tests a month prior to surgery, a month after surgery and three months after surgery |
| unilateral | – | Procedure: respiratory function testsunilateral breast construction candidates will go through respiratory function tests a month prior to surgery, a month after surgery and three months after surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients elected for breast reconstruction surgery using tissue expander-implant technique
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| respiratory function testsFVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP | Procedure or surgery | bilateral, unilateral |
Primary outcome
Forced vital capacity -FVC
Time frame: a month prior to surgery
Forced vital capacity: the determination of the vital capacity from a maximally forced expiratory effort
Forced expiratory volume at one second -FEV1
Time frame: a month prior to surgery
Volume that has been exhaled at the end of the first second of forced expiration
Maximum voluntary ventilation-MVV
Time frame: a month prior to surgery
Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort
Functional residual capacity-FRC
Time frame: a month prior to surgery
Functional residual capacity: the volume in the lungs at the end-expiratory position
Residual volume -RV
Time frame: a month prior to surgery.
Residual volume: the volume of air remaining in the lungs after a maximal exhalation.
Total lung capacity-TLC
Time frame: a month prior to surgery.
Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.
Maximal inspiratory pressure-MIP
Time frame: a month prior to surgery.
Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece
Maximal expiratory pressure-MEP
Time frame: a month prior to surgery.
Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.
Forced vital capacity -FVC
Time frame: a month after surgery
Forced vital capacity: the determination of the vital capacity from a maximally forced
Forced vital capacity -FVC
Time frame: three months after surgery
Forced vital capacity: the determination of the vital capacity from a maximally forced
Forced expiratory volume at one second -FEV1
Time frame: a month after surgery
Volume that has been exhaled at the end of the first second of forced expiration
Forced expiratory volume at one second -FEV1
Time frame: three months after surgery
Volume that has been exhaled at the end of the first second of forced expiration
Maximum voluntary ventilation-MVV
Time frame: a month after surgery
Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort
Maximum voluntary ventilation-MVV
Time frame: three months after surgery
Maximal voluntary ventilation: volume of air expired in a specified period during repetitive maximal effort
Functional residual capacity-FRC
Time frame: a month after surgery
Functional residual capacity: the volume in the lungs at the end-expiratory position
Functional residual capacity-FRC
Time frame: three months after surgery
Functional residual capacity: the volume in the lungs at the end-expiratory position
Residual volume -RV
Time frame: a month after surgery
Residual volume: the volume of air remaining in the lungs after a maximal exhalation.
Residual volume -RV
Time frame: three months after surgery
Residual volume: the volume of air remaining in the lungs after a maximal exhalation.
Total lung capacity-TLC
Time frame: a month after surgery.
Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.
Total lung capacity-TLC
Time frame: three months after surgery.
Total lung capacity: the volume in the lungs at maximal inflation, the sum of VC and RV.
Maximal inspiratory pressure-MIP
Time frame: a month after surgery
Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece
Maximal inspiratory pressure-MIP
Time frame: three months after surgery.
Maximal inspiratory pressure (MIP) is the maximal pressure that can be produced by the patient trying to inhale through a blocked mouthpiece
Maximal expiratory pressure-MEP
Time frame: a month after surgery.
Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.
Maximal expiratory pressure-MEP
Time frame: three months after surgery.
Maximal expiratory pressure (MEP) is the maximal pressure measured during forced expiration (with cheeks bulging) through a blocked mouthpiece after a full inhalation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Background: PubMed 10084371Terakado 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.
- Background: PubMed 17218889Legrand 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.
- Background: PubMed 16838222Legrand 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.
- Background: PubMed 25640018Lomax 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.
- Background: PubMed 6510353Machado 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.
- Background: PubMed 1856417Mancini 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.
- Background: PubMed 23954833Matusiewicz 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.
- Background: PubMed 16195992Moalla 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.
- Background: PubMed 16497096Ogata 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.
- Background: PubMed 14757996Ogata 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.
- Background: PubMed 975981Reid 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.
- Background: PubMed 14927261TOKIZANE 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Har-Shai, Proffesor principal investigator
Carmel Medical Center-Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Function and Breast Reconstruction, run by Yaron Har-Shai at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaron Har-Shai, Proffesor (0507866206, yaron07@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity -FVC (time frame: a month prior to surgery). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02491762, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.