Effect of PEEP=5cmH2O vs PEEP=0cmH2O PSV Strategies During SBT on Successful Disconnection From Mechanical Ventilation (PPSDMV-RCT)
June 17, 2021 updated by: Liu ZiMeng, First Affiliated Hospital, Sun Yat-Sen University
Effect of PEEP=5cmH2O vs PEEP=0cmH2O PSV Strategies During SBT on Successful Disconnection From Mechanical Ventilation: A Randomized Clinical Trial
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.
Study Overview
Detailed Description
Patients who met the withdrawal screening criteria were randomly divided into groups for self-breathing test by PSV method with low pressure support level.
Parameters of each group were as follows.
In the experimental group, PS = 8 cmH2O, PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT.The control group: PSV mode, PS = 8 cmH2O, PEEP=0 cmH2O, FiO2 level was consistent with that before SBT.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.Endotracheal intubation was removed if the patient was successfully assessed for spontaneous breathing.
Record the date and time of extubation.Patients with endotracheal intubation were treated with nasal hyperflow oxygen therapy for respiratory support.Patients with SBT failure were reconnected to the ventilator, and mechanical ventilation was given according to the ventilation mode and parameters before the spontaneous breathing test.The reasons for SBT failure were recorded and these patients were not randomized to SBT.If respiratory failure occurs within 48 hours after extubation, the attending physician decides the respiratory treatment plan.These patients were also not included in the subsequent SBT randomization.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ZiMeng Liu, Doctor
- Phone Number: 020-87755766-8454
- Email: sumslzm@163.com
Study Locations
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Guangdong
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Guanzhou, Guangdong, China, 510080
- Recruiting
- The first affiliated hospital of SunYatSen University
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Contact:
- Liu Zimeng, doctor
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1) Older than 18;
- 2) Patients with mechanical ventilation for 24h;
- 3) Meet the screening standards for daily disconnection;
- 4) 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.
Exclusion Criteria:
- 1) Patients undergoing tracheotomy;
- 2) Patients who refuse to be intubated again after endotracheal intubation is removed;
- 3) Patients on long-term mechanical ventilation: mechanical ventilation duration was continuous for 21 days, >6 h/d;
- 4) The attending physician decides the withdrawal plan (e.g., the potential pathology is more favorable to the specific withdrawal plan).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PEEP=5cmH2O
In PSV mode,PS = 8 cmH2O,PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT
|
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.
|
|
Experimental: PEEP=0cmH2O
In PSV mode,PS = 8 cmH2O,PEEP=0 cmH2O, and FiO2 level was consistent with that before SBT
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Extubation success rate
Time Frame: during 48 hours after the first SBT
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The success rate of extubation (during 48 hours after the first SBT if successfully removed from the ventilator).
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during 48 hours after the first SBT
|
|
Reintubation rate
Time Frame: during 48 hours after extubation
|
The reintubation rate of respiratory failure after extubation.
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during 48 hours after extubation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reintubation rate at 72 hours
Time Frame: during 72 hours after extubation
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Reintubation rate at 72 h
|
during 72 hours after extubation
|
|
No mechanical ventilation duration in ICU
Time Frame: From first transfer in ICU to transfer out ICU up to 28 days after randomization
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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
Time Frame: From admission to discharge from ICU up to 28 days after randomization
|
Length of ICU stay
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From admission to discharge from ICU up to 28 days after randomization
|
|
ICU mortality, 28-day mortality
Time Frame: 28 day
|
ICU mortality, 28-day mortality
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28 day
|
|
Results of blood gas analysis
Time Frame: every 30 min during SBT up one hour to and 30min after extubation
|
PaCO2 and PaO2 (SBT screening, SBT completion, 30min after extubation)
|
every 30 min during SBT up one hour to and 30min after extubation
|
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Respiratory mechanical parameters
Time Frame: every 30 min during SBT up to one hour
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lung compliance monitoring： Static and dynamic lung compliance
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every 30 min during SBT up to one hour
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Predictors of withdrawal of patients on mechanical ventilation
Time Frame: every 30 min during SBT up one hour and before extubation
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airway occlusion pressure
|
every 30 min during SBT up one hour and before extubation
|
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Predictors of withdrawal of patients on mechanical ventilation
Time Frame: every 30 min during SBT up one hour and before extubation
|
negativeinspiratory force
|
every 30 min during SBT up one hour and before extubation
|
|
Predictors of withdrawal of patients on mechanical ventilation
Time Frame: every 30 min during SBT up to one hour and before extubation
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Rapid Shallow Breathing Index
|
every 30 min during SBT up to one hour and before extubation
|
|
Vital signs
Time Frame: every 15 min during SBT up to one hour and 30 min after extubation
|
Heart Rate
|
every 15 min during SBT up to one hour and 30 min after extubation
|
|
Vital signs
Time Frame: every 15 min during SBT up to one hour and 30 min after extubation
|
SpO2
|
every 15 min during SBT up to one hour and 30 min after extubation
|
|
Vital signs
Time Frame: every 15 min during SBT up to one hour and 30 min after extubation
|
Blood Pressure
|
every 15 min during SBT up to one hour and 30 min after extubation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chest electrical impedance imaging (EIT)
Time Frame: from the start to the end of SBT up to one hour and 30min after extubation
|
region of interests(RI),Center of Ventilation(COV),end expiratory lung inmpedance(EELI), △EELi
|
from the start to the end of SBT up to one hour and 30min after extubation
|
|
Subjective score of patients with dyspnea
Time Frame: every 30 min during SBT up to one hour and 30min after extubation
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Score 0-10: 0 for no dyspnea, 10 for severe dyspnea
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every 30 min during SBT up to one hour and 30min after extubation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: ZiMeng Liu, Doctor, First Affiliated Hospital, Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: Am J Respir Crit Care Med 1997 Dec;156(6):2028.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: JAMA. 2019 Aug 20;322(7):696.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2020
Primary Completion (Anticipated)
August 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
June 7, 2020
First Submitted That Met QC Criteria
June 17, 2021
First Posted (Actual)
June 25, 2021
Study Record Updates
Last Update Posted (Actual)
June 25, 2021
Last Update Submitted That Met QC Criteria
June 17, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020761001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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