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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03348085
Other study ID # 04-XD25-067
Secondary ID
Status Completed
Phase N/A
First received November 16, 2017
Last updated November 21, 2017
Start date January 1, 2016
Est. completion date December 31, 2016

Study information

Verified date January 2016
Source Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. purpose of study: optimal minute could be the prediction of successful weaning and become the new weaning parameter.

2. study design: inclusion criteria: investigators will perform this study at our respiratory care center. Patients who had been maintained on mechanical ventilator in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had ailed.

Exclusion criteria: Patients do not have spontaneous breath. Terminal cancer stage and unstable hemodynamics condition.

3. study duration: 2016/01/01~12/31


Description:

Investigators will preform this study at our respiratory care center. Initially, Investigators collected all physiological parameters and baseline characteristics of patients with prolong mechanical ventilator. Investigators use Gold-Galileo ventilator and patients use adaptive support ventilation mode. In adaptive support ventilation, the clinician enters a target minute volume , using a parameter called minute ventilation percentage. The minute ventilation percentage setting be initially set at 100% (the 100%minute ventilation setting), which provides a target minute ventilation of 0.1 L/min/kg of ideal body weight . Investigators observed respiratory frequency of patients, the minute ventilation percentage was increased every 5 min until the mandatory breath began to appear and spontaneous rate is zero. If the minute ventilation percentage had exceeded 250%, but patients do not have mandatory rate appeared, the optimal minute ventilation of the patient is means above 250%. Investigators also measure other weaning parameters. Finally, Investigators analyze the prediction of optimal minute ventilation as a weaning parameter.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patients who had been maintained on mechanical ventilation in excess of 3 weeks before respiratory care center admission and all previous weaning attempts had failed.

Exclusion Criteria:

- Patients do not have spontaneous breath. Patients do not use invasive mechanical ventilator. Terminal cancer stage and hemodynamics unstable.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

References & Publications (11)

Frutos-Vivar F, Esteban A. Critical illness polyneuropathy: a new (or old?) reason for weaning failure. Crit Care Med. 2005 Feb;33(2):452-3. — View Citation

King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002. Review. — View Citation

Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447. — View Citation

MacIntyre NR, Epstein SK, Carson S, Scheinhorn D, Christopher K, Muldoon S; National Association for Medical Direction of Respiratory Care. Management of patients requiring prolonged mechanical ventilation: report of a NAMDRC consensus conference. Chest. 2005 Dec;128(6):3937-54. — View Citation

Ntoumenopoulos G. Rehabilitation during mechanical ventilation: Review of the recent literature. Intensive Crit Care Nurs. 2015 Jun;31(3):125-32. doi: 10.1016/j.iccn.2015.02.001. Epub 2015 May 27. Review. — View Citation

OTIS AB, MCKERROW CB, BARTLETT RA, MEAD J, MCILROY MB, SELVER-STONE NJ, RADFORD EP Jr. Mechanical factors in distribution of pulmonary ventilation. J Appl Physiol. 1956 Jan;8(4):427-43. — View Citation

Scheinhorn DJ, Artinian BM, Catlin JL. Weaning from prolonged mechanical ventilation. The experience at a regional weaning center. Chest. 1994 Feb;105(2):534-9. — View Citation

Schönhofer B. [Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously]. Pneumologie. 1997 Jun;51(6):599-600. German. — View Citation

Verceles AC, Diaz-Abad M, Geiger-Brown J, Scharf SM. Testing the prognostic value of the rapid shallow breathing index in predicting successful weaning in patients requiring prolonged mechanical ventilation. Heart Lung. 2012 Nov-Dec;41(6):546-52. doi: 10.1016/j.hrtlng.2012.06.003. Epub 2012 Jul 6. — View Citation

Wu CP, Lin HI, Perng WC, Yang SH, Chen CW, Huang YC, Huang KL. Correlation between the %MinVol setting and work of breathing during adaptive support ventilation in patients with respiratory failure. Respir Care. 2010 Mar;55(3):334-41. — View Citation

Wu YK, Tsai YH, Lan CC, Huang CY, Lee CH, Kao KC, Fu JY. Prolonged mechanical ventilation in a respiratory-care setting: a comparison of outcome between tracheostomized and translaryngeal intubated patients. Crit Care. 2010;14(2):R26. doi: 10.1186/cc8890. Epub 2010 Mar 1. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The prediction of optimal minute ventilation as successful weaning parameters in patients with prolong mechanical ventilator. Investigators observed the condition of patients with adaptive spontaneous ventilation mode that the patient admitted to respiratory care center first day 2016/01/01~2016/12/31,1 year
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