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Follow-up Study of Patients Undergoing Cardiac Surgery (Follow-up01)

2015년 8월 13일 업데이트: Fernanda Menezes de Siqueira Santana Alves, Centro Universitário de Votuporanga

Follow-up Study of Functional Capacity and Respiratory Muscle Strength in Patients Undergoing Cardiac Surgery

Countless studies are performed to quantify the severity of heart disease and its influence on the respiratory system, checking that their heart conditions and the surgical process determine pulmonary complications, one of the most common causes of morbidity and mortality in the postoperative period of cardiac surgery . After surgical procedures, there is a reduction of the residual volume (RV), total lung capacity (TLC), vital capacity (VC) and functional residual capacity (FRC), leading to the formation of atelectasis, with alterations in the ventilation-perfusion ( V / Q), the partial pressure of carbon dioxide in arterial blood (PaCO2) and partial pressure of oxygen in arterial blood (PaO 2).

Pulmonary function is impaired in the postoperative period of cardiac surgery, due to various factors common to this major surgery that will drive the patient to develop respiratory complications such as atelectasis and pneumonia. Physical therapy plays an important role in the treatment of patients undergoing cardiac surgery, both in the preoperative period and postoperative, in order to prevent or minimize the respiratory complications.

Follow-up studies on cardiac rehabilitation quantify the quality of all the activities necessary to ensure to patients with heart disease patients the best physical , mental and social conditions so that consequently they are able , with its effort to regain a normal position in the community and lead a active and productive life over time, therefore, the clinical changes resulting from an extensive cardiac surgery are already highly dedicated described in literature but which daily life factors or rehabilitation interventions that the patient will take in the late postoperative period that really assisted in his complete recovery and inclusion into society they are still not well elucidated , so it is appropriate to carry out this project due to the fact exposed to up.

The project to be developed whose main justification clarify issues related to the return or preservation of the individual feature that undergoes extensive cardiac procedure , as well as incidence of mortality after 12 months of the procedure. The current literature does not expressed clearly, possible impacts on functionality and return the daily activities of the individual in the late postoperative period , since such malfunctions in the immediate post operative period are already fully understood.

연구 개요

상태

알려지지 않은

상세 설명

Will be held during the period from August to November 2015, quantitative descriptive transversal study with patients in the late postoperative period and who underwent cardiac surgery in a hospital of medium complexity in state of sao paulo , Brazil in the period to one year of the procedure. Patients will be recruited via contact by phone to attend in place with certain pre scheduled time for carrying out assessments relevant to the study.

Evaluations shall be performed in hospital in predetermined track, under the sun and accompanied by the examiners. All individuals will be properly oriented and participate in the activities after signing the informed consent (Informed Consent and Informed).

Will be held primarily refers to report cards and progress retroactive filled by students physiotherapy course that evaluated the functional condition and respiratory muscle strength of these individuals included in the study at the time of hospital discharge in cardiac surgical post (last year). The purpose of the consultation of these records is to determine the functional clinical characteristics of these individuals soon after surgery to corroborate the results of these same tests in these patients one year after participants' surgery as well being able to quantify the influence of a number of situations that occurred in the lives of these individuals who may modify in any way the current situation both clinical and social thereof. These evaluation sheets are filed at the physiotherapy clinic.

After consulting retroactive chips, a full interview will be held with the participant, assessing quality of life through specific scores (SF-36), evaluation of daily living habits, social life, work life, independence, recurrent admissions this the participation period of rehabilitation programs and cease habits like smoking, drinking and physical inactivity.

The clinical trials will be conducted: quantification of inspiratory and expiratory muscle strength through the determination of maximal inspiratory pressure (MIP.) And maximal expiratory pressure (MEP.) Using the device which measures and submaximal functional testing through the application of Walk Test 6 minutes (TC6').

The patient will be taken to the track to be traveled for the test and hemodynamic data were to be collected at rest, during and after the test are: blood pressure, heart rate, oxygen saturation.

The patient should be instructed to walk as fast as you can without running, as recommended by the American ThoracicSociety, on a track of 30 meters, marked every 3 meters, with the turning point. By completing the six minutes, the patient should stop immediately. In this way it will be measured the total distance covered by the patient and again all variables at the time of arrest.

The parameters checked during the whole test should be noted , as the distance traveled in meters.

At the end of quantification of clinical and epidemiological data, previous history and current data comparison will be made in order to determine the physical and functional characteristics of these patients in monitoring the late postoperative period .

연구 유형

중재적

등록 (예상)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • São Paulo
      • Votuporanga, São Paulo, 브라질, 15.500 - 003
        • Santa Casa

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Hemodynamic stability during the tests to be performed
  • Post surgical period of one year,
  • The level of awareness and appropriate collaboration for instructions and commanding voice and no weakness in the march.
  • The surgeon responsible for the surgical procedure the patient must sign a statement authorizing the patient to participate in the study by answering the interview and conduct the walk test.

Exclusion Criteria:

  • Need for interruption of fatigue by tests
  • Dyspnea,
  • Exercise intolerance proposed
  • Pains of any kind or expressed will of the patient to stop the activities.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: cardiac surgery
Surgical cardiac procedures despite benefiting the clinical condition of the patient with potential increased survival and reduced risk of death can cause both immediate and long-term functional changes that may influence the appropriate re-inclusion of this individual the daily life practices as well as labor and social activities. Such changes resulting from surgical procedures in the short term are already well documented but the occurrence of these same changes in the late period and its influence on patient's daily lives are not well documented.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Assessment of functional capacity in cardiac surgery through the six-minute walk test
기간: 3 months
Evaluate the postoperative function of patients undergoing cardiac surgery.
3 months

2차 결과 측정

결과 측정
측정값 설명
기간
quality of life through the SF - 36 (The Short Form (36) Health Survey)
기간: 3 months
Determine the impact of intrinsic and extrinsic factors related to the surgical procedure that impact the quality of life of long-term individuals.
3 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 8월 1일

기본 완료 (예상)

2015년 8월 1일

연구 완료 (예상)

2015년 12월 1일

연구 등록 날짜

최초 제출

2015년 8월 11일

QC 기준을 충족하는 최초 제출

2015년 8월 13일

처음 게시됨 (추정)

2015년 8월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 8월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 8월 13일

마지막으로 확인됨

2015년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • UNIFEV01

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

마음; 기능 장애 수술 후, 심장 수술에 대한 임상 시험

cardiac surgery에 대한 임상 시험

구독하다