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Early CPAP And Large Volume Minimally Invasive Surfactant (ECALMIST) in Preterm Infants With RDS (ECALMIST)

2013년 6월 18일 업데이트: Yahya Al Ethawi, University of Manitoba

Feasibility of Using Early CPAP (Continuous Positive Airway Pressure) And Large Volume Minimal Invasive Surfactant Therapy (ECALMIST) in Preterm Infants With Respiratory Distress Syndrome (RDS)

Modification of Minimally Invasive Surfactant Therapy (MIST) to a new technique called ECALMIST (Early CPAP And Large volume Minimal Invasive Surfactant). This modification is needed to adapt the use of large volume surfactant of 4-5 ml/kg.

The ECALMIST will be used to deliver the large volume Surfactant that been used in Canada called BLES (about 5 ml for each 100 mg) to the preterm infants bellow 35 weeks gestation suffer from respiratory distress syndrome (RDS) in 1st 24 hours of life while maintained on CPAP.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

The 5 ml/Kg surfactant is warm to room temperature. Using standard laryngoscope without premedication while the infant is maintained on continuous positive airway pressure (CPAP. The the laryngoscope should be removed after stabilizing the vascular catheter between 2 fingers at the level of lips (weight +6 cm). The surfactant will be administer by boluses of 0.25 -0.5 ml at a time over 20-30 seconds and 10 seconds apart while maintain the vital signs.

The procedure should be stopped if the vital signs deteriorate, CPAP pressure and oxygen requirement might need to adjusted to restore baseline vital signs. If the vital signs remained unstable the catheter should be removed and the infant managed according by positive pressure ventilation (PPV) or intubation by endotracheal tube (ETT).

At the end of the procedure the catheter should be flushed with 0.5 ml of air then catheter should be removed.

FiO2 (fraction of inspired oxygen), oxygen saturation and CPAP pressure will be recorded before during and after the procedure.

Complication like bradycardia (Hear rate below 100 beat per minute) or Apnea (pause of respiration for more than 20 second or less than 20 seconds but associated with bradycardia) All other neonatal outcome will be recorded (IVH [Intra-ventricular Hemorrhage], ROP [Retinopathy of prematurity], duration of ventilation, duration of hospital stay, infection, duration of oxygen requirement and others.

연구 유형

중재적

등록 (실제)

21

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

  • 캐나다
    • Manitoba
      • Winnipeg, Manitoba, 캐나다
        • St. Boniface Hospital
      • Winnipeg, Manitoba, 캐나다, R3C0L8
        • Children hospital of health Sciences Center
      • Winnipeg, Manitoba, 캐나다, R3C0L8
        • Women's Hospital Health Science Center

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

10분 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

-preterm infants less than 35 weeks gestation in 1st day of life with RDS and spontaneously breathing on CPAP and need surfactant administration.

Exclusion Criteria:

  • Infants needs of mechanical ventilation
  • Congenital anomaly
  • Respiratory distress due to non RDS related causes.
  • no parental consent

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: ECALMIST
Large volume 5ml/kg surfactant administered by vascular catheter while maintaining CPAP or ECALMIST; Early CPAP (continuous positive airway pressure) And Large volume Minimal Invasive Surfactant Therapy
장치: ECALMIST
Labelled catheter at level of the lips (6 cm plus weight) will inserted through the vocal cords under direct vision using a standard laryngoscope without premedication while maintaining CPAP. 5 ml/kg surfactant syringe will be connected to the catheter hub and 0.25-0.5 ml was administered; then the syringe will be disconnected from the catheter to observe the surfactant moving up and down or coming back as indication of accurate intubation of the trachea. The surfactant the slowly administer by boluses of 0.25-0.5 ml over 20-30 seconds with 10 seconds apart. At the end of the procedure, the operator flushed the catheter with 0.5 ml of air before removing the catheter while maintaining CPAP
다른 이름들:
  • Surfactant administration by catheter
장치: ECALMIST
Vascular catheter of 1.6 French size of 133 mm length 16 gauge used to deliver the BLES; a large volume surfactant while maintain CPAP
다른 이름들:
  • Surfactant administration by catheter

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Early Ventilation Hours
기간: 72 hours
The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing
72 hours

2차 결과 측정

결과 측정
측정값 설명
기간
Incidence of Bradycardia During Procedure
기간: Range of 10 minutes
Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.
Range of 10 minutes
Saturation During the Procedure
기간: 10 minutes
Level of oxygen which is measured by oxygen pulse Oximetry. It is express as proportion out of one which is equal to percentage of 100. The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.
10 minutes
Failure to Catheterized the Trachea by the Vascular Catheter
기간: 20 seconds
Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.
20 seconds
Index Before the Procedure
기간: 1 hour

The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.

FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure.
1 hour
CPAP Pressure After the Procedure
기간: 4 hours
Continuous positive airway pressure (CPAP) is measured in centimeter of water
4 hours
Oxygen Requirement Before the Procedure
기간: 1 hour
Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
1 hour
Oxygen Saturation After the Procedure
기간: 4 hours
Oxygen saturation is measured by pulse oximetry. It is express as proportion out of 1 (decimal) that is equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
4 hours
Index After the Procedure
기간: 4 hours

The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.

FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure.
4 hours
CPAP Pressure Before the Proceudre
기간: 1 hour
Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)
1 hour
Oxygen Saturation Before the Procedure
기간: 1 hour
Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.
1 hour
Oxygen Requirements After the Procedure
기간: 4 hours
Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100. The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.
4 hours
Needs for Intubation During the Procedure
기간: 10 minutes
The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)
10 minutes

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Manitoba

수사관

  • 수석 연구원: Yahya Al Ethawi, MD, University of Manitoba

간행물 및 유용한 링크

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

유용한 링크

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

2012년 4월 1일

기본 완료 (실제)

2012년 9월 1일

연구 완료 (실제)

2012년 9월 1일

연구 등록 날짜

최초 제출

2012년 3월 6일

QC 기준을 충족하는 최초 제출

2012년 3월 13일

처음 게시됨 (추정)

2012년 3월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 7월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 6월 18일

마지막으로 확인됨

2013년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B2012:016

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. .

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