NCT04939285

Brief Summary

Mechanical ventilation is the most common means of life support in intensive care unit. Daily spontaneous breathing trial (SBT) is the most effective method to evaluate whether patients on mechanical ventilation can be removed from the ventilator, thus reducing mechanical ventilation duration and ventilator-related complications. Pressure support ventilation and T-piece ventilation are the two most commonly used SBT methods, lasting from 30 minutes to 2 hours. However, the parameter setting for SBT using PSV method has not been completely agreed, especially regarding the use of positive end-expiratory pressure (PEEP). Therefore, we intend to conduct a single-center, prospective, randomized, controlled study to evaluate the impact of PEEP=0cmH2O and PEEP=5cmH2O on extubation success rate and re-intubation rate in mechanically ventilated patients, to provide high-level clinical evidence on the use of PEEP for SBT in patients with mechanical ventilation, so as to reduce the duration of mechanical ventilation and complications related to mechanical ventilation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
1 year until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

June 7, 2020

Last Update Submit

June 17, 2021

Conditions

Respiration, Artificial

Keywords

PEEPpressure support ventilationSBT

Outcome Measures

Primary Outcomes (2)

  • Extubation success rate

    The success rate of extubation (during 48 hours after the first SBT if successfully removed from the ventilator).

    during 48 hours after the first SBT

  • Reintubation rate

    The reintubation rate of respiratory failure after extubation.

    during 48 hours after extubation

Secondary Outcomes (12)

  • Reintubation rate at 72 hours

    during 72 hours after extubation

  • No mechanical ventilation duration in ICU

    From first transfer in ICU to transfer out ICU up to 28 days after randomization

  • Length of ICU stay

    From admission to discharge from ICU up to 28 days after randomization

  • ICU mortality, 28-day mortality

    28 day

  • Results of blood gas analysis

    every 30 min during SBT up one hour to and 30min after extubation

  • +7 more secondary outcomes

Other Outcomes (2)

  • Chest electrical impedance imaging (EIT)

    from the start to the end of SBT up to one hour and 30min after extubation

  • Subjective score of patients with dyspnea

    every 30 min during SBT up to one hour and 30min after extubation

Study Arms (2)

PEEP=5cmH2O

EXPERIMENTAL

In PSV mode,PS = 8 cmH2O,PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT

Procedure: PEEP

PEEP=0cmH2O

EXPERIMENTAL

In PSV mode,PS = 8 cmH2O,PEEP=0 cmH2O, and FiO2 level was consistent with that before SBT

Procedure: PEEP

Interventions

PEEPPROCEDURE

The patients who met the withdrawal screening criteria were randomly divided into low pressure support level PSV spontaneous respiration test.The duration of the spontaneous breathing test was 30 minutes, and the results of the spontaneous breathing test were evaluated at the end of the test.

PEEP=0cmH2OPEEP=5cmH2O

Eligibility Criteria

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

You may qualify if:

  • \) Older than 18;
  • \) Patients with mechanical ventilation for 24h;
  • \) Meet the screening standards for daily disconnection;
  • \) The study complies with the Declaration of Helsinki and China's regulations on clinical trial research, and the patient or his/her family members have informed and agreed to participate in the study.

You may not qualify if:

  • \) Patients undergoing tracheotomy;
  • \) Patients who refuse to be intubated again after endotracheal intubation is removed;
  • \) Patients on long-term mechanical ventilation: mechanical ventilation duration was continuous for 21 days, \>6 h/d;
  • \) The attending physician decides the withdrawal plan (e.g., the potential pathology is more favorable to the specific withdrawal plan).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of SunYatSen University

Guanzhou, Guangdong, 510080, China

RECRUITING

Related Publications (16)

  • Esteban A, Frutos F, Tobin MJ, Alia I, Solsona JF, Valverdu I, Fernandez R, de la Cal MA, Benito S, Tomas R, et al. A comparison of four methods of weaning patients from mechanical ventilation. Spanish Lung Failure Collaborative Group. N Engl J Med. 1995 Feb 9;332(6):345-50. doi: 10.1056/NEJM199502093320601.

    PMID: 7823995BACKGROUND

  • Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM, Browder RW, Bowton DL, Haponik EF. Effect on the duration of mechanical ventilation of identifying patients capable of breathing spontaneously. N Engl J Med. 1996 Dec 19;335(25):1864-9. doi: 10.1056/NEJM199612193352502.

    PMID: 8948561BACKGROUND

  • Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue JM, Blanco J, Carriedo D, Leon M, de la Cal MA, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS. Extubation outcome after spontaneous breathing trials with T-tube or pressure support ventilation. The Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):459-65. doi: 10.1164/ajrccm.156.2.9610109.

    PMID: 9279224BACKGROUND

  • Esteban A, Alia I, Tobin MJ, Gil A, Gordo F, Vallverdu I, Blanch L, Bonet A, Vazquez A, de Pablo R, Torres A, de La Cal MA, Macias S. Effect of spontaneous breathing trial duration on outcome of attempts to discontinue mechanical ventilation. Spanish Lung Failure Collaborative Group. Am J Respir Crit Care Med. 1999 Feb;159(2):512-8. doi: 10.1164/ajrccm.159.2.9803106.

    PMID: 9927366BACKGROUND

  • Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.

    PMID: 12185425BACKGROUND

  • Sklar MC, Burns K, Rittayamai N, Lanys A, Rauseo M, Chen L, Dres M, Chen GQ, Goligher EC, Adhikari NKJ, Brochard L, Friedrich JO. Effort to Breathe with Various Spontaneous Breathing Trial Techniques. A Physiologic Meta-analysis. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1477-1485. doi: 10.1164/rccm.201607-1338OC.

    PMID: 27768396BACKGROUND

  • Pellegrini JA, Moraes RB, Maccari JG, de Oliveira RP, Savi A, Ribeiro RA, Burns KE, Teixeira C. Spontaneous Breathing Trials With T-Piece or Pressure Support Ventilation. Respir Care. 2016 Dec;61(12):1693-1703. doi: 10.4187/respcare.04816. Epub 2016 Sep 6.

    PMID: 27601720BACKGROUND

  • Burns KEA, Soliman I, Adhikari NKJ, Zwein A, Wong JTY, Gomez-Builes C, Pellegrini JA, Chen L, Rittayamai N, Sklar M, Brochard LJ, Friedrich JO. Trials directly comparing alternative spontaneous breathing trial techniques: a systematic review and meta-analysis. Crit Care. 2017 Jun 1;21(1):127. doi: 10.1186/s13054-017-1698-x.

    PMID: 28576127BACKGROUND

  • Li Y, Li H, Zhang D. Comparison of T-piece and pressure support ventilation as spontaneous breathing trials in critically ill patients: a systematic review and meta-analysis. Crit Care. 2020 Feb 26;24(1):67. doi: 10.1186/s13054-020-2764-3.

    PMID: 32102693BACKGROUND

  • Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.

    PMID: 31184740BACKGROUND

  • Schmidt GA, Girard TD, Kress JP, Morris PE, Ouellette DR, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Truwit JD. Liberation From Mechanical Ventilation in Critically Ill Adults: Executive Summary of an Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline. Chest. 2017 Jan;151(1):160-165. doi: 10.1016/j.chest.2016.10.037. Epub 2016 Nov 3.

    PMID: 27818329BACKGROUND

  • El-Khatib MF, Zeineldine SM, Jamaleddine GW. Effect of pressure support ventilation and positive end expiratory pressure on the rapid shallow breathing index in intensive care unit patients. Intensive Care Med. 2008 Mar;34(3):505-10. doi: 10.1007/s00134-007-0939-x. Epub 2007 Dec 1.

    PMID: 18060662BACKGROUND

  • Futier E, Constantin JM, Petit A, Jung B, Kwiatkowski F, Duclos M, Jaber S, Bazin JE. Positive end-expiratory pressure improves end-expiratory lung volume but not oxygenation after induction of anaesthesia. Eur J Anaesthesiol. 2010 Jun;27(6):508-13. doi: 10.1097/EJA.0b013e3283398806.

    PMID: 20404729BACKGROUND

  • Ostberg E, Thorisson A, Enlund M, Zetterstrom H, Hedenstierna G, Edmark L. Positive End-expiratory Pressure Alone Minimizes Atelectasis Formation in Nonabdominal Surgery: A Randomized Controlled Trial. Anesthesiology. 2018 Jun;128(6):1117-1124. doi: 10.1097/ALN.0000000000002134.

    PMID: 29462011BACKGROUND

  • Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.

    PMID: 31587835BACKGROUND

  • Cabello B, Thille AW, Roche-Campo F, Brochard L, Gomez FJ, Mancebo J. Physiological comparison of three spontaneous breathing trials in difficult-to-wean patients. Intensive Care Med. 2010 Jul;36(7):1171-9. doi: 10.1007/s00134-010-1870-0. Epub 2010 Mar 30.

    PMID: 20352189BACKGROUND

Related Links

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ZiMeng Liu, Doctor

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ZiMeng Liu, Doctor

CONTACT

020-87755766-8454sumslzm@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 25, 2021

Study Start

June 10, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

June 25, 2021

Record last verified: 2021-06

Locations

CN(1)