- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Observasjonsmessig
Registrering (Antatt)
400
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Lan Lan, PHD
- Telefonnummer: +8602083062566
- E-post: lanlan@gzhmu.edu.cn
Studer Kontakt Backup
- Navn: Fengfa Yang, BS
- Telefonnummer: +8602083062566
- E-post: yff18312377134@163.com
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510120
- The First Affiliated Hospital of Guangzhou Medical University
-
Ta kontakt med:
- Lan Lan, PHD
- Telefonnummer: +8602083062566
- E-post: lanlan@gzhmu.edu.cn
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients who underwent elective non-anatomic partial lung resection surgery at the First Affiliated Hospital of Guangzhou Medical University
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Concentration of cognitive function biomarkers in the serum samples of 400 patients
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anesthesia Record Form
Tidsramme: at the end of the surgery (T2)
|
Record the vital signs at the T2 time point
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at the end of the surgery (T2)
|
|
Case information system collection
Tidsramme: 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
Tidsramme: During the operation
|
Record the intraoperative conditions
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During the operation
|
|
Postoperative follow-up records
Tidsramme: 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
Tidsramme: 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
Tidsramme: through study completion, an average of 1 year
|
the postoperative hospital stay
|
through study completion, an average of 1 year
|
|
Postoperative follow-up records
Tidsramme: through study completion, an average of 1 year
|
the total hospitalization cost
|
through study completion, an average of 1 year
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative follow-up records
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Lan Lan, PHD, The First Affiliated Hospital of Guangzhou Medical University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
20. juli 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
13. juli 2026
Først innsendt som oppfylte QC-kriteriene
19. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ES-2025-216-02
- GMUCR2025-02011 (Annet stipend/finansieringsnummer: Guangzhou Medical University)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Patient clinical data
Tilgangskriterier for IPD-deling
The data can be obtained by email from Lan Lan (Email: lanlan@gzhmu.edu.cn) for clinical requirements.
IPD-deling Støtteinformasjonstype
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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