- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07721038
A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Spontaneous Breathing and the Double-lumen Bronchial Intubation on the Brain Health During the Perioperative Period
19 juli 2026 uppdaterad av: Fengfa Yang, Guangzhou Medical University
Tubeless Anesthesia With Preserved Spontaneous Breathing and the Construction of a Perioperative Brain Health Safety System for Thoracic Surgery Patients Study 2: A Prospective Clinical Study Observing the Impact of Two Anesthesia Techniques-Tubeless With Preserved Spontaneous Breathing Versus Double-Lumen Endotracheal Intubation-on Perioperative Brain Health
This project conducts a prospective cohort study.
By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire (APS-POQ-R), Mini-Mental State Examination (MMSE), as well as perioperative stress and related indicators, hypothalamic-pituitary-adrenal axis (HPA) endocrine indicators, sublingual microcirculation, electroencephalogram, etc., comprehensive assessment is made of the correlations between the two different anesthesia methods of Tubeless retention of spontaneous breathing and double-lumen bronchial intubation and postoperative sleep, chronic pain and cognitive function, to construct a perioperative brain health safety system to improve prognosis; at the same time, optimize the perioperative sedation and analgesia plan and promote the postoperative brain health recovery of patients.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Observationell
Inskrivning (Beräknad)
400
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Lan Lan, PHD
- Telefonnummer: +8602083062566
- E-post: lanlan@gzhmu.edu.cn
Studera Kontakt Backup
- Namn: Fengfa Yang, BS
- Telefonnummer: +8602083062566
- E-post: yff18312377134@163.com
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
Kontakt:
- Lan Lan, PHD
- Telefonnummer: +8602083062566
- E-post: lanlan@gzhmu.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients who underwent elective non-anatomic partial lung resection surgery at the First Affiliated Hospital of Guangzhou Medical University
Beskrivning
Inclusion Criteria:
- Patient age: 18 - 75 years old
- Patients meeting the standards of the American Society of Anesthesiologists (ASA) I-III grade and the New York Heart Association (NYHA) I-II class
- Body Mass Index (BMI) < 30 kg/m2
- Intraoperative blood loss less than 300 ml
- No severe cardiac or pulmonary dysfunction [first-second forced vital capacity (FEV1%) predicted value] > 50%, ejection fraction (EF) > 50%
- No contraindications related to paravertebral nerve block and intercostal nerve block
- Able to sign the informed consent form and possess communication, reading and writing abilities
- Postoperative hospital stay of at least one day
- No preoperative sleep disorders, no cognitive dysfunction (PSQI ≤ 10 points, PCS ≤ 38 points, MMSE > 27 points)
Exclusion Criteria:
- Already diagnosed with a mental disorder or had a preoperative Mini-Mental State Examination (MMSE) score of less than 27
- History of opioid abuse
- Patients who were admitted to the ICU after surgery
- Have severe cardiovascular, respiratory diseases
- Experienced critical rescue during or after the surgery
- Complicated with coagulation dysfunction, severe hypoxia or hypercapnia, or liver and kidney dysfunction
- Difficult airway management
- Changed anesthetic agent or surgical plan
- Severe lacunar cerebral infarction, ischemic stroke or other neurological diseases
- Changed anesthetic agent or surgical plan during the surgery;
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
tubeless group
Patients undergoing elective non-anatomic partial lung resection surgery using the Tubeless technique for maintaining spontaneous breathing anesthesia
|
|
double-lumen bronchial intubation group
Patients undergoing elective non-anatomic lung segmentectomy surgery using the double-lumen bronchial tube anesthesia method
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Concentration of cognitive function biomarkers in the serum samples of 400 patients
Tidsram: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
|
At time points T1, T2, and T3, 5 ml of peripheral venous blood was collected to test the biological indicators of postoperative cognitive function.
|
Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
|
|
Concentrations of HPA axis-related indicators in the serum samples of 400 patients
Tidsram: Before the start of the surgery (T1), at the end of the surgery (T2)
|
At the TI-T2 time point, 5 ml of peripheral venous blood was collected for the detection of HPA axis-related indicators.
|
Before the start of the surgery (T1), at the end of the surgery (T2)
|
|
The concentrations of laboratory test indicators in the serum samples of 400 patients
Tidsram: Before the start of the surgery (T1), and on the first day after the surgery (T3)
|
Record the laboratory test indicators at time points T1 and T3
|
Before the start of the surgery (T1), and on the first day after the surgery (T3)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Anesthesia Record Form
Tidsram: at the end of the surgery (T2)
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Record the vital signs at the T2 time point
|
at the end of the surgery (T2)
|
|
Case information system collection
Tidsram: Before the start of the surgery (T1), and on the first day after the surgery (T3)
|
Record the pulmonary function, chest X-ray or chest CT at time points T1 and T3
|
Before the start of the surgery (T1), and on the first day after the surgery (T3)
|
|
Anesthesia Record Form
Tidsram: During the operation
|
Record the intraoperative conditions
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During the operation
|
|
Postoperative follow-up records
Tidsram: through study completion, an average of 1 year
|
Record the time of chest tube removal after surgery
|
through study completion, an average of 1 year
|
|
Postoperative follow-up records
Tidsram: through study completion, an average of 1 year
|
the usage of postoperative analgesic drugs
|
through study completion, an average of 1 year
|
|
Postoperative follow-up records
Tidsram: through study completion, an average of 1 year
|
the postoperative hospital stay
|
through study completion, an average of 1 year
|
|
Postoperative follow-up records
Tidsram: through study completion, an average of 1 year
|
the total hospitalization cost
|
through study completion, an average of 1 year
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative follow-up records
Tidsram: through study completion, an average of 1 year
|
Record the occurrence of adverse events during the perioperative period
|
through study completion, an average of 1 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Lan Lan, PHD, The First Affiliated Hospital of Guangzhou Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
20 juli 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
31 december 2028
Studieregistreringsdatum
Först inskickad
13 juli 2026
Först inskickad som uppfyllde QC-kriterierna
19 juli 2026
Första postat (Faktisk)
22 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ES-2025-216-02
- GMUCR2025-02011 (Annat bidrag/finansieringsnummer: Guangzhou Medical University)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Patient clinical data
Kriterier för IPD Sharing Access
The data can be obtained by email from Lan Lan (Email: lanlan@gzhmu.edu.cn) for clinical requirements.
IPD-delning som stöder informationstyp
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .