NCT00000572

Brief Summary

To compare conventional therapy using low frequency positive pressure ventilation with extracorporeal CO2 removal for the treatment of adult respiratory distress syndrome (ARDS).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 1987

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1987

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1991

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1993

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

3.8 years

First QC Date

October 27, 1999

Last Update Submit

March 4, 2018

Conditions

Acute Respiratory Distress SyndromeLung Diseases

Outcome Measures

Primary Outcomes (1)

  • Survival

    All deaths occurred within 30 days of enrollment

    Hospital stay (time until death): participants will be followed for the duration of hospital stay, an expected average of 30 days).

Secondary Outcomes (2)

  • Hospital days

    up to hospital discharge, approximately 30 days

  • ICU days

    up to ICU discharge, approximately 30 days

Other Outcomes (2)

  • Hospital costs

    Hospital stay

  • Bleeding/Hemorrhage

    Hospital stay

Study Arms (2)

Extracorporeal membrane oxygenation (CO2 removal)

EXPERIMENTAL

Detailed Electronic Protocol Controlled Extracorporeal CO2 Removal with reduced positive-pressure ventilation

Procedure: extracorporeal membrane oxygenation (CO2 removal)

Protocol Controlled positive-pressure vent

ACTIVE COMPARATOR

Detailed Electronic Protocol Controlled positive-pressure ventilation

Procedure: positive-pressure ventilation

Interventions

positive-pressure ventilationPROCEDURE

Detailed computer protocol controlled positive pressure ventilation

Protocol Controlled positive-pressure vent
extracorporeal membrane oxygenation (CO2 removal)PROCEDURE

Detailed computer protocol controlled Extracorporeal CO2 Removal with reduced positive pressure ventilation

Extracorporeal membrane oxygenation (CO2 removal)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rapid entry: 2 hours at fraFIO2=1.00 and PEEP\>5 cm H2O with PaCO2=30-45 mmHg
  • Slow entry: 12 hours at fraction of inspired oxygen (FIO2)\>0.60 and positive end-expiratory pressure (PEEP)\>5 cm H2O with PaCO2=30-45 mmHg and right to Left shunt fraction \>0.30

You may not qualify if:

  • Contraindication to anti-coagulation (for example, gastrointestinal bleeding, recent cerebrovascular accident, or chronic bleeding disorder).
  • Pw \> 25 mm Hg (superseded by our screening criterion that Pw \~ 15 mm Hg).
  • Mechanical ventilation \>21. days.
  • Severe chronic systemic disease or another clinical condition that, in itself,greatly limits survival; for example,
  • Irreversible central nervous system disease
  • Severe chronic pulmonary disease (forced expiratory volume in 1 second (FEV1)\<1 L, FEV1/FVC(forced vital capacity) \<0.3 of predicted, chronic PaCO2 \>45 mm Hg, chest x-ray evidence of overinflation or interstitial infiltration, or previous hospitalization for chronic respiratory insufficiency)
  • Total-body surface burns\> 40%
  • Rapidly fatal malignancy
  • Chronic left ventricular failure
  • Chronic renal failure (we required serum creatlnlne \~ 2 mg/dl or chronic dialysis therapy)
  • Chronic liver failure (we required total serum bilirubin;?; 2 mg/dl)
  • Immunosuppressed patients and patients with a positive human immu.. nodeficiency virus test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • Morris AH, Menlove RL, Rollins RJ, Wallace CJ, Beck E. A controlled clinical trial of a new 3-step therapy that includes extracorporeal CO2 removal for ARDS. ASAIO Trans. 1988 Jan-Mar;34(1):48-53. No abstract available.

    PMID: 3132189BACKGROUND

  • Sittig DF, Gardner RM, Pace NL, Morris AH, Beck E. Computerized management of patient care in a complex, controlled clinical trial in the intensive care unit. Comput Methods Programs Biomed. 1989 Oct-Nov;30(2-3):77-84. doi: 10.1016/0169-2607(89)90060-6.

    PMID: 2684495BACKGROUND

  • Sittig DF, Pace NL, Gardner RM, Beck E, Morris AH. Implementation of a computerized patient advice system using the HELP clinical information system. Comput Biomed Res. 1989 Oct;22(5):474-87. doi: 10.1016/0010-4809(89)90040-2.

    PMID: 2776450BACKGROUND

  • Sittig DF, Gardner RM, Morris AH, Wallace CJ. Clinical evaluation of computer-based respiratory care algorithms. Int J Clin Monit Comput. 1990 Jul;7(3):177-85. doi: 10.1007/BF02915583.

    PMID: 2250128BACKGROUND

  • Suchyta MR, Elliott CG, Colby T, Rasmusson BY, Morris AH, Jensen RL. Open lung biopsy does not correlate with pulmonary function after the adult respiratory distress syndrome. Chest. 1991 May;99(5):1232-7. doi: 10.1378/chest.99.5.1232.

    PMID: 2019184BACKGROUND

  • Suchyta MR, Clemmer TP, Orme JF Jr, Morris AH, Elliott CG. Increased survival of ARDS patients with severe hypoxemia (ECMO criteria). Chest. 1991 Apr;99(4):951-5. doi: 10.1378/chest.99.4.951.

    PMID: 2009801BACKGROUND

  • Henderson S, Crapo RO, Wallace CJ, East TD, Morris AH, Gardner RM. Performance of computerized protocols for the management of arterial oxygenation in an intensive care unit. Int J Clin Monit Comput. 1991-1992;8(4):271-80. doi: 10.1007/BF01739128.

    PMID: 1820417BACKGROUND

  • East TD, Morris AH, Wallace CJ, Clemmer TP, Orme JF Jr, Weaver LK, Henderson S, Sittig DF. A strategy for development of computerized critical care decision support systems. Int J Clin Monit Comput. 1991-1992;8(4):263-9. doi: 10.1007/BF01739127.

    PMID: 1820416BACKGROUND

  • Suchyta MR, Clemmer TP, Elliott CG, Orme JF Jr, Weaver LK. The adult respiratory distress syndrome. A report of survival and modifying factors. Chest. 1992 Apr;101(4):1074-9. doi: 10.1378/chest.101.4.1074.

    PMID: 1555423BACKGROUND

  • East TD, Bohm SH, Wallace CJ, Clemmer TP, Weaver LK, Orme JF Jr, Morris AH. A successful computerized protocol for clinical management of pressure control inverse ratio ventilation in ARDS patients. Chest. 1992 Mar;101(3):697-710. doi: 10.1378/chest.101.3.697.

    PMID: 1541135BACKGROUND

  • Morris AH, East TD, Wallace CJ, Orme J Jr, Clemmer T, Weaver L, Thomas F, Dean N, Pearl J, Rasmusson B. Ethical implications of standardization of ICU care with computerized protocols. Proc Annu Symp Comput Appl Med Care. 1994:501-5.

    PMID: 7949979BACKGROUND

  • Morris AH. Adult respiratory distress syndrome and new modes of mechanical ventilation: reducing the complications of high volume and high pressure. New Horiz. 1994 Feb;2(1):19-33.

    PMID: 7922426BACKGROUND

  • Morris AH. Uncertainty in the management of ARDS: lessons for the evaluation of a new therapy. Intensive Care Med. 1994;20(2):87-9. doi: 10.1007/BF01707658. No abstract available.

    PMID: 8201102BACKGROUND

  • Suchyta MR, Elliott CG, Jensen RL, Crapo RO. Predicting the presence of pulmonary function impairment in adult respiratory distress syndrome survivors. Respiration. 1993;60(2):103-8. doi: 10.1159/000196182.

    PMID: 8341851BACKGROUND

  • Morris AH. Protocol management of adult respiratory distress syndrome. New Horiz. 1993 Nov;1(4):593-602.

    PMID: 8087579BACKGROUND

  • Morris AH, Wallace CJ, Menlove RL, Clemmer TP, Orme JF Jr, Weaver LK, Dean NC, Thomas F, East TD, Pace NL, Suchyta MR, Beck E, Bombino M, Sittig DF, Bohm S, Hoffmann B, Becks H, Butler S, Pearl J, Rasmusson B. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):295-305. doi: 10.1164/ajrccm.149.2.8306022.

    PMID: 8306022RESULT

  • Habashi NM, Reynolds HN, Borg U, Cowley RA. Randomized clinical trial of pressure-controlled inverse ration ventilation and extra corporeal CO2 removal for ARDS. Am J Respir Crit Care Med. 1995 Jan;151(1):255-6. doi: 10.1164/ajrccm.151.1.7812567. No abstract available.

    PMID: 7812567RESULT

  • Brunet F, Mira JP, Dhainaut JF, Dall'ava-Santucci J. Efficacy of low-frequency positive-pressure ventilation-extracorporeal CO2 removal. Am J Respir Crit Care Med. 1995 Apr;151(4):1269-70. doi: 10.1164/ajrccm/151.4.1269-a. No abstract available.

    PMID: 7697266RESULT

  • Falke KJ. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):1016-7. No abstract available.

    PMID: 9310029RESULT

MeSH Terms

Conditions

Respiratory Distress SyndromeLung Diseases

Interventions

Positive-Pressure RespirationExtracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory TherapyExtracorporeal CirculationSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of Research, Pulmonary Division

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

June 1, 1987

Primary Completion

April 1, 1991

Study Completion

January 1, 1993

Last Updated

March 6, 2018

Record last verified: 2018-03