하부기도 협착증이 있는 성인 환자의 호흡에 관한 Heliox의 연구
하부기도 협착증이 있는 성인 환자의 호흡 작용에 대한 Heliox의 효과
Heliox (a mixture of Helium and Oxygen) can reduce the work of breathing in patients with airway stenosis by modifying turbulent flow into laminar flow. The aim of this study was to analyze the effect of Heliox versus conventional oxygen therapy in patients with lower airway stenosis on muscular effort measured by electromyography and diaphragmatic ultrasound, thoracoabdominal synchrony assessed with plethysmographic bands, dyspnea, stridor, oxygen saturation, transcutaneous carbon dioxide value, blood pressure, heart rate and respiratory rate.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Lower airway stenosis results in increased work of breathing with stridor and dyspnea, as a consequence of the increased resistances caused by the reduction in airway diameter. Airway resistance also depends on the length of the airway and the type of gas flow. Heliox (a mixture of Helium and Oxygen) is a gas less dense than air, which can change the flow from turbulent to laminar, reducing airway resistance by 20 to 40%, and therefore decreasing the work of breathing. Heliox is an inert gas that does not react with biological membranes, so there are few complications associated with its use, the most relevant being hypoxemia when fixed mixtures are not used and the the fraction of inspired oxygen (FiO2) supplied is less than 21%. The aim of the study was to evaluate if during the perioperative period of lower airway stenosis the administration of Heliox compared to oxygen could reduce the work of breathing and improve dyspnea. For this purpose, patients were treated for 30 minutes with Heliox (fixed mixture of 70% helium and 30% oxygen) using a non rebreather mask or reservoir bag versus 30 minutes with oxygen 31% using a Venturi mask.
연구 유형
연구 유형
등록 (실제)
등록
연락처 및 위치
연구 장소
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-
Madrid
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Madrid, Madrid, 스페인, 28041
- Marta Corral Blanco
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre
설명
Inclusion Criteria:
- Patients with lower airway stenosis evaluated at the Respiratory Endoscopy Unit of the Hospital Universitario 12 de Octubre on the waiting list for endoscopic intervention on stenosis.
- Stenosis grade ≥ 3 and Borg scale score > 2.
Exclusion Criteria:
- Presence of relevant comorbidities (uncontrolled ischemic heart disease, ventricular dysfunction, pneumopathies with severe respiratory insufficiency, severe pulmonary hypertension).
- Inability to perform the test due to severe dyspnea or need for emergency intervention.
- Patient on continuous mechanical ventilation, invasive or non-invasive.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Airway Stenosis
Patients with lower airway stenosis on waiting list for endoscopic intervention on stenosis by respiratory endoscopy unit. |
Treatment for 30 minutes with Heliox from a commercial tank (Oxhelⓒ, Air Liquideⓒ) with a fixed mixture of 70% helium and 30% oxygen with non-rebreather mask or reservoir bag at a flow of 12-15 lpm.
다른 이름들:
Treatment for 30 minutes with oxygen at FiO2 of 31% with Venturi mask.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Neural Ventilatory Drive (%):
기간: 30 minutes with Heliox and 30 minutes with Oxygen 31%
|
Percentage over the Root Mean Square peak for parasternal electromyography (EMG): averaged of the square root of the peak value and the area under the curve of parasternal EMG (%RootMeanSquare) adjusted for respiratory frequency, as a surrogate of diaphragmatic EMG, and sternocleidomastoid EMG, which will give us information on accessory muscle activation. |
30 minutes with Heliox and 30 minutes with Oxygen 31%
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diaphragmatic excursion assessed with ultrasound
기간: At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
|
Assessment of muscular effort by measuring the diaphragmatic excursion (mm) at tidal volume and at vital capacity. |
At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
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Thickening fraction of the diaphragm assessed by ultrasound
기간: At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
|
Assessment of muscular effort by measuring the thickening fraction of the diaphragm in the apposition zone (%). |
At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
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|
Changes in thoracoabdominal synchrony
기간: Phase angle was calculated from 10 consecutive breaths at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Assessment of thoracoabdominal synchrony using thoracic and abdominal belts by calculating the phase angle with the Lissajoux loop method (plotting abdominal motion on the x-axis against thoracic motion on the y-axis). |
Phase angle was calculated from 10 consecutive breaths at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Borg Scale Dyspnea evolution (points)
기간: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Oxygen saturation
기간: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Measured by pulse-oximetry |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Transcutaneous partial pressure of carbon dioxide
기간: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2) |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
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Blood pressure
기간: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Non-invasive measurement with a sphygmomanometer |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
|
Heart rate
기간: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
number of beats per minute |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
|
Respiratory rate
기간: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Number of breaths per minute |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Marta Corral Blanco, MD, Hospital 12 de Octubre
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- HELIOX ON AIRWAY STENOSIS
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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