Effects of Volume Guarantee With Pressure Supported vs. Synchronized Intermittent Mandatory Ventilation in VLBW Infants

NCT00295230 | Suspended

• 1 other identifier: 0512098
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Studies in preterm infants have shown that adding volume guarantee (VG) to synchronized modes of ventilation is not only feasible but also advantageous for providing more constant and desirable mechanical breath size. This ideally minimizes ventilator-induced lung injury due to barotrauma and volutrauma. To date, only one recent study has investigated the relative advantages of combining VG with different modes of synchronized mechanical ventilation in clinically stable, preterm infants that were mechanically ventilated at an average age of one month. We aim to further evaluate the effects of PSV+VG versus SIMV+VG ventilation in very low birth weight infants within the first three to five days of life. Our hypothesis is that in very low birth weight infants requiring mechanical ventilation in the first three to five days of life, PSV+VG will allow for more stable physiologic and ventilatory parameters compared to SIMV+VG. The primary endpoints are a reduction in respiratory rate and average mean airway pressure in the PSV+VG group compared to the SIMV+VG group.

Conditions

Respiratory Distress Syndrome

Keywords

respiratory distress syndrome; very low birth weight infant; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Respiratory rate

  6hr

Secondary Outcomes (2)

• Ventilator variables

  6hr

• Vital signs

  6hr

Interventions

PSV+VG mode versus SIMV+VG mode PROCEDURE

fully assisted mechanical ventilation versus assistance on only a select number of breaths

Eligibility Criteria

• Age: 72 Hours - 120 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

premature infants weighing \</= 1500 grams and needing mechanical ventilation at 72-120 hours of age.

You may qualify if:

• Infants will be recruited based on the following criteria: weight ≤1500 grams and need for mechanical ventilation at 72 - 120 hours of age. Recruitment will continue until 16 patients have completed the study

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead
• Windtree Therapeutics: collaborator

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (5)

• Cheema IU, Ahluwalia JS. Feasibility of tidal volume-guided ventilation in newborn infants: a randomized, crossover trial using the volume guarantee modality. Pediatrics. 2001 Jun;107(6):1323-8. doi: 10.1542/peds.107.6.1323.

  PMID: 11389251 BACKGROUND

• Herrera CM, Gerhardt T, Claure N, Everett R, Musante G, Thomas C, Bancalari E. Effects of volume-guaranteed synchronized intermittent mandatory ventilation in preterm infants recovering from respiratory failure. Pediatrics. 2002 Sep;110(3):529-33. doi: 10.1542/peds.110.3.529.

  PMID: 12205255 BACKGROUND

• Keszler M, Abubakar K. Volume guarantee: stability of tidal volume and incidence of hypocarbia. Pediatr Pulmonol. 2004 Sep;38(3):240-5. doi: 10.1002/ppul.20063.

  PMID: 15274104 BACKGROUND

• Mrozek JD, Bendel-Stenzel EM, Meyers PA, Bing DR, Connett JE, Mammel MC. Randomized controlled trial of volume-targeted synchronized ventilation and conventional intermittent mandatory ventilation following initial exogenous surfactant therapy. Pediatr Pulmonol. 2000 Jan;29(1):11-8. doi: 10.1002/(sici)1099-0496(200001)29:13.0.co;2-5.

  PMID: 10613781 BACKGROUND

• Abubakar K, Keszler M. Effect of volume guarantee combined with assist/control vs synchronized intermittent mandatory ventilation. J Perinatol. 2005 Oct;25(10):638-42. doi: 10.1038/sj.jp.7211370.

  PMID: 16094389 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Mark Mammel, MD

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 23, 2006
• Study Start: February 1, 2006
• Study Completion: September 1, 2007
• Last Updated: November 7, 2007

Record last verified: 2007-11

Locations

US (1)