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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEP=5cmH2O | Experimental | In PSV mode,PS = 8 cmH2O,PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT |
|
| PEEP=0cmH2O | Experimental | In PSV mode,PS = 8 cmH2O,PEEP=0 cmH2O, and FiO2 level was consistent with that before SBT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEP | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation rate at 72 hours | Reintubation rate at 72 h | during 72 hours after extubation |
| No mechanical ventilation duration in ICU | No mechanical ventilation duration in ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Chest electrical impedance imaging (EIT) | region of interests(RI),Center of Ventilation(COV),end expiratory lung inmpedance(EELI), â–³EELi | from the start to the end of SBT up to one hour and 30min after extubation |
| Subjective score of patients with dyspnea |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZiMeng Liu, Doctor | Contact | 020-87755766-8454 | sumslzm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ZiMeng Liu, Doctor | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of SunYatSen University | Recruiting | Guanzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7823995 | Background | 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. | |
| 8948561 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| From first transfer in ICU to transfer out ICU up to 28 days after randomization |
| Length of ICU stay | Length of ICU stay | From admission to discharge from ICU up to 28 days after randomization |
| ICU mortality, 28-day mortality | ICU mortality, 28-day mortality | 28 day |
| Results of blood gas analysis | PaCO2 and PaO2 (SBT screening, SBT completion, 30min after extubation) | every 30 min during SBT up one hour to and 30min after extubation |
| Respiratory mechanical parameters | lung compliance monitoring： Static and dynamic lung compliance | every 30 min during SBT up to one hour |
| Predictors of withdrawal of patients on mechanical ventilation | airway occlusion pressure | every 30 min during SBT up one hour and before extubation |
| Predictors of withdrawal of patients on mechanical ventilation | negativeinspiratory force | every 30 min during SBT up one hour and before extubation |
| Predictors of withdrawal of patients on mechanical ventilation | Rapid Shallow Breathing Index | every 30 min during SBT up to one hour and before extubation |
| Vital signs | Heart Rate | every 15 min during SBT up to one hour and 30 min after extubation |
| Vital signs | SpO2 | every 15 min during SBT up to one hour and 30 min after extubation |
| Vital signs | Blood Pressure | every 15 min during SBT up to one hour and 30 min after extubation |
Score 0-10: 0 for no dyspnea, 10 for severe dyspnea
| every 30 min during SBT up to one hour and 30min after extubation |
| 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. |
| 9279224 | Background | 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. |
| 9927366 | Background | 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. |
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| 27768396 | Background | 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. |
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| 31184740 | Background | 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. |
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| 20404729 | Background | 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. |
| 29462011 | Background | 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. |
| 31587835 | Background | 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. |
| 20352189 | Background | 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. |
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