- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05696860
Microstream® kapnografi i endobronchial ultralydsapplikationer under sedation
Effekten af Microstream®-kapnografi på patientsikkerhed i endobronkial ultralydsapplikationer under sedation
Formål: Forskere ønskede at undersøge effekten af kapnografimonitorering ud over rutinemonitorering på udviklingen af desaturation og andre vitale parametre i tilfælde af endobronkial ultralyd (EBUS).
Metode: 100 patienter, der gennemgik EBUS under sedation, vil blive inkluderet i denne prospektive og randomiserede kontrollerede undersøgelse. Sagerne vil blive delt op i to grupper på hver 50 personer. I den første gruppe vil der blive udført standardmonitorering, og i den anden gruppe vil der udover standardmonitorering blive anvendt kapnografimonitorering. Hjertefrekvens, blodtryk, perifer iltmætning (SpO2) værdier i begge grupper, end-tidal kuldioxid (EtCO2), respirationsfrekvens og integreret pulmonal indeks (IPI) værdier i den anden gruppe vil blive registreret i alle tilfælde. Forstyrrelser i vitale parametre og luftvejsinterventioner, som var almindelige i begge grupper, vil blive sammenlignet. Hyppigheden af problemer opdaget ved kapnografiovervågning i den anden gruppe vil blive undersøgt.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Endobronchial ultrasonography (EBUS) is an examination method that has been increasingly used in diagnosing and staging lung cancer, mediastinal lymphadenopathy and masses in recent years. This procedure is performed under anesthesia. General anesthesia or sedation is generally preferred as an anesthesia option. Desaturation may frequently develop during this procedure. Follow-up with standard perioperative monitoring methods (heart rate - HR, respiratory rate - SS, peripheral oxygen saturation - SpO2) is not a proper approach to detecting respiratory depression before desaturation develops.
Capnography is a monitoring method that detects respiratory depression before desaturation develops by making instant end-tidal carbon dioxide (EtCO2) measurements. It has been stated that it significantly reduces the risk of desaturation in many surgical and interventional procedures performed under sedation and general anesthesia. In addition, respiratory disorders such as bronchospasm, apnea or hypopnea can be detected by capnography. However, there is no information about capnography's effect on desaturation development or its contribution to standard monitoring in EBUS cases.
The purpose of this study was to investigate the effects of capnography monitoring in addition to routine monitoring on the development of desaturation and other vital parameters in EBUS cases under moderate sedation according to the Ramsay Sedation Scale (RSS). The primary aim was to compare the groups in terms of the development of desaturation, and the secondary aim was in terms of duration of hypoxemia, development of severe hypoxemia, lowest SpO2 value, development of hypotension, and bradycardia.
150 patients who will undergo elective EBUS procedure, have scores between 1-3 according to the American Society of Anesthesiologists (ASA) classification, are pregnant or not suspected of pregnancy, approve the informed consent form, and are not allergic to the sedation agents to be used, will be included in the study. Patients with an ASA score of 4 and above, pregnant or suspected pregnancy, patients with difficult airway features, and emergency cases will be excluded from the study.
The cases will be divided into two groups of 75 people using the closed envelope method. There will be cases in which capnography monitorization was performed in group 1 (experimental group), and cases in which capnography monitoring was not performed in group 2 (control group). In all cases, age, gender, weight, height, ASA class, doses of applied anesthesia drugs, and smoking history will be recorded. After obtaining informed consent in all cases Standard monitoring and BIS monitoring will be performed before sedation, including HR, SS, SpO2, BP, and 3-lead electrocardiographic analysis. In addition to standard monitoring in patients in Group 1, ETCO2, integrated pulmonary index (IPI) will be measured non-invasively prior to sedation through a nasal cannula (FilterLine®) connected to the capnography device (Capnostream® 20p). Sedation and analgesia will be performed in accordance with the routine sedation-analgesia protocol used by our department in EBUS cases. There will be no changes to the routine protocol. In accordance with this protocol, after the patient is taken to the operating room, 5 ml of 2% lidocaine will be applied with a reservoir mask for topical anesthesia. As a sedative agent, 1-2 mg of midazolam will be administered intravenously. A nasopharyngeal airway will be placed and 5 lt/min oxygen will be given to all patients throughout the operation. In induction, remifentanil will be administered at a level of 0.04 µg/kg/min and Propofol at a level of 0.5-1 mg/kg/hour. The target sedation level will be determined as 60-80 BIS score and will be level 3 (moderate sedation, sleepy but responsive to verbal stimuli) according to the Ramsey Sedation Scale. All parameters measured before sedation in both groups; It will be recorded at 3 minutes, 6 minutes, 9 minutes after sedation, and at 3-minute intervals until the end of the operation.
During the operation, in the cases in Group 1, apnea (the ETCO2 waveform is not seen for 10 seconds), hypopnea (at least 50% decrease in the peak ETCO2 level in 2 consecutive waveforms compared to the initial value and the peak ETCO2 level in the second wave is lower than the first) and the number of bronchospasm, The number of episodes of cough, tachycardia, bradycardia, hypoxemia (SpO2<90%) in both groups, duration of anesthesia, duration of the procedure (time between insertion and removal of the bronchoscope) and recovery time (spontaneous opening of the eyes of the patients with the removal of the bronchoscope, performing the finger-nose test) and the time elapsed between the time he was able to tell his birth dates) will be recorded. If bronchospasm, upper airway obstruction, apnea, bradypnea develop during the procedure, jaw-thrust maneuvers, head-tilt maneuvers, verbal and tactile warnings will be recorded.
After the operation, the cases will be taken to the recovery unit. From the moment of entry in the recovery unit; BP, EtCO2, SpO2 and IPI values will be recorded every 5 minutes until the exit time. In accordance with the routine sobering protocol; Patients with a Modified Aldrete Score of 9 or higher will be sent to the clinic.
The frequency and interrelationship of the parameters evaluated in both groups will be examined. Between the group that underwent capnography and the group that did not; It will be investigated whether there is a significant difference in terms of apnea, desaturation episodes and interventions.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Bursa, Kalkun
- Bursa Uludag University Department of Anesthesiology and Reanimation
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) score of 1-3,
- No pregnancy or suspected pregnancy
- No allergy history
- Signed informed consent
Exclusion Criteria:
- Emergency EBUS cases
- ASA score of 4
- Allergy or pregnancy history
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Overvågning med kapnografi
Patienterne fulgtes med kapnografi og standardovervågning
|
Kapnografi overvågning
|
|
Ingen indgriben: Overvågning uden kapnografi
Patienter fulgt med standardovervågning
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Desaturationsudvikling - Perifer iltmætning falder med mindre end 90 % på pulsoximetri
Tidsramme: During Sedation, an average of 1 hour
|
Compare Experimental and Control Groups in Terms of Desaturation Development
|
During Sedation, an average of 1 hour
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Fatma Nur Kaya, supervisor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BUU2019/8-18
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .