- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00686257
Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
연구 개요
상태
정황
상세 설명
Despite its demonstrated efficacy in treating selected patients with acute respiratory failure, the application of NPPV is still plagued by a substantial failure rate, ranging from below 10% to above 40%. Mask intolerance ranks as one of the most common causes of failure. This is related to ill-fitting masks, mask discomfort (despite a properly fitted mask), excessively tightened straps, excessive air leaks around the mask or through the mouth, and claustrophobia.
The most commonly used masks in the acute care setting are either oronasal masks that cover the nose and mouth, or nasal masks that cover the nose alone. Both mask types usually consist of clear plastic dome-shaped mask with a soft silicon gasket to create an air seal with the skin. While this approach is usually successful, it may lead to patient discomfort and/or an air leak secondary to the difficulty in creating an effective seal over the bridge of the nose and over mobile structures such as the mandible. The Total Face Mask ™ (Respironics, Inc., Pittsburgh, PA) uses a different approach to avoid some of these limitations. Considerably larger than a standard oronasal mask, it covers the entire face and creates an air seal using a silicon gasket around the parameter of the face. In this way, gasket pressure is more evenly distributed, and discomfort over the bridge of the nose or chin is eliminated, and air leaking reduced. In addition, because one mask size fits virtually all patients, the Total Face Mask ™ facilitates the fitting process and permits more rapid initiation of ventilatory assistance. Clinical experience to date suggests that claustrophobia is not a common problem with the Total Face Mask ™ despite its size, and that its contribution to dead space is comparable to that of most oronasal masks.
The following protocol aims to compare use of the Total Face Mask ™ to the Comfort Full oronasal mask (also by Respironics, Inc., Pittsburgh, PA)or RT040 oronasal mask (Fisher&Paykel Inc., Wellington, NZ) in the acute care setting for patients meeting standard indications for NPPV.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02111
- Tufts Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age>18
- Either A or B
A. Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.
B. Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2>45 with a pH<7.35, or a PaO2/FiO2 ratio<200.
Exclusion Criteria:
- The need for immediate intubation
- Medical instability such as hypotensive shock, uncontrolled cardiac ischemia or arrythmias, unstable myocardial infarction, uncontrolled upper gastrointestinal bleeding
- Agitation or uncooperativeness, unresponsive to small doses of sedatives
- Excretions or inability to protect the airway
- Inability to fit the mask
- Facial trauma
- Upper airway obstruction
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 1
Patients receiving NPPV by the 'Total Face Mask'
|
NPPV is applied by this mask, as long as NPPV is received.
다른 이름들:
|
|
활성 비교기: 2
Patients receiving NPPV by 'standard oronasal mask'
|
NPPV is applied by one of these masks (Comfort full or RT040 masks used at Rhode Island Hospital and Tufts Medical Center respectively), as long as NPPV is received.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
기간: During the first 3 hours of recruitment
|
During the first 3 hours of recruitment
|
|
Time Required for Mask Placement
기간: at the initiation of NPPV
|
at the initiation of NPPV
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Early NIV Discontinuation Rate
기간: During hospitalization period (after recruitment into the study)
|
Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support
|
During hospitalization period (after recruitment into the study)
|
|
Deterioration Vital Signs
기간: during the first 24 hours of the study
|
during the first 24 hours of the study
|
|
|
Deterioration in Gas Exchange
기간: during the first 24 hours of the study
|
during the first 24 hours of the study
|
|
|
Total Length of Time Requiring NIV
기간: during hospitalization (after recruitment)
|
during hospitalization (after recruitment)
|
|
|
Length of Hospital Stay
기간: during hospitalization (after recruitment)
|
during hospitalization (after recruitment)
|
|
|
In-hospital Mortality Rate
기간: during hospitalization (after recruitment)
|
during hospitalization (after recruitment)
|
공동 작업자 및 조사자
수사관
- 연구 의자: Aylin Ozsancak, MD, research fellow
- 수석 연구원: Nicholas S. Hill, MD, Chair of Pulmonary, Critical Care and Sleep Division
- 연구 책임자: Samy Sidhom, MD, MPH, Clinical Fellow
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB-6060
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. .