Pneumonia Clinical Trial
— STABALOfficial title:
The Influences of Standardized Procedure of Bronchoalveolar Lavage on the Diagnosis of Pneumonia Pathogen of Critical Patients
In order to improve the accuracy of the diagnosis of pulmonary pathogens and reduce the adverse impact of excessive BAL volume on patients, this study intends to explore the most optimal lavage volume in the middle lobe and the lower lobe of critical patients as well as seeking for the best way to manage BALF samples by means of detecting alveolar proteins and bacterial composition in BALF samples. The hypothesis is that the optimal lavage volume in the middle lobe and the lower lobe might be different. And to sample BALF separately through sequential lavage might be a better way to improve the accuracy of the diagnosis of pneumonia pathogens.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Admitted to intensive care unit - Mechanically ventilated patient - 18 years old or above - Pneumonia diagnosed by one of 1 - 4 plus 5 1. purulent endotracheal secretions or increasing oxygen requirements; 2. body temperature exceeds 38.0 ?; 3. potentially pathogenic bacteria be isolated from the endotracheal secretions; 4. leukocyte count exceeds 10×10^9 per liter or less than 4×10^9 per liter; 5. new or persistent radiographic features of pneumonia without another obvious cause. Exclusion Criteria: - considered to be unsuitable for bronchoscopy by attending physician; - underwent bronchoalveolar lavage within the last 48 hours; - medical history of lobectomy - airway bleeding or pulmonary edema - refuse to sign the informed consent |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Wu Jianfeng |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The optimal lavage volume at the middle lobe and the lower lobe, evaluated by the detection of SP-B, SP-D and HT?-56 in bronchoalveolar lavage fluid (BALF). | For the reason that SP-B, SP-D and HT?-56 only exists in terminal airway and alveolus, the concentrations of them in BALF indicates the abundance of terminal airway materials obtained by bronchoalveolar lavage. SP-B, SP-D and HT?-56 will be detected by enzyme-linked immunosorbent assay (ELISA). | 48 hours | |
Primary | The best way to manage BALF samples, evaluated by comparing the bacterial diversity and abundance in separately collected BALF specimens and mixed BALF specimen. | Mixed BALF specimen was a mixture of one tenth of separately collected BALF specimens. The BALF specimens will be cultured at 37?,5% carbon dioxide for 18 to 24 hours, using blood ager, chocolate ager and MacConkey ager. Bacterial species will be identified by matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) and the colony counts will be recorded. Besides, BALF specimens will also be dectected by Next Generation Sequencing for the bacterial diversity and abundance. As a reference, culture of the endotracheal aspiration will be conducted. | 3 days | |
Secondary | Quality of BALF samples, evaluated by counts of different kind of cells in BALF | The living cells of BALF will be counted by Trypan blue staining. And the proportion of squamous cell and columnar cell will be counted by Wright-Giemsa staining. | 24 hours | |
Secondary | Recovery of bronchoalveolar lavage fluid | To record the volume of bronchoalveolar lavage fluid (BALF) recovered and calculate the recovery. | 1 hour | |
Secondary | Impact of bronchoalveolar lavage (BAL) on the cardiovascular system. | To observe the systolic arterial blood pressure (SAP), diastolic arterial blood pressure (DAP), mean arterial pressure (MAP) and heart rate (HR). | 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours, 19 hours and 24 hours after BAL | |
Secondary | Change of pulmonary static compliance (Cst). | Cst will be measured with mechanical ventilator (Drager EvitaXL, Germany). | 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL. | |
Secondary | Chang of airway resistance (Raw). | Raw will be measured with mechanical ventilator (Drager EvitaXL, Germany). | 30 minutes before BAL; 15 minutes, 1 hours, 3 hours, 9 hours and 24 hours after BAL. | |
Secondary | Change of PaO2/FiO2 ratio. | PaO2 denotes the arterial oxygen partial pressure and FiO2 denotes the fraction of inspired oxygen. | About 2 hours before BAL; 15 minutes, 3 hours, 9 hours, 19 hours and 24 hours after BAL. | |
Secondary | Change of arterial carbon dioxide partial pressure (PaCO2). | PaCO2 will be measured by arterial blood gas analysis. | About 2 hours before BAL; 15 minutes, 3 hours, 9 hours, 19 hours and 24 hours after BAL. |
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