- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05133375
Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
Comparison of Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
After taking approval from hospital ethical committee, 272 patients who reported to Operation Theatre of CMH, Jhelum were selected for the study. Informed consent was obtained and patient demographic information (name, age, contact) was recorded. Patients were randomly divided in two equal groups by using lottery method. GROUP A: Where Macintosh laryngoscope was used for endotracheal intubation. GROUP B: Where McCoy laryngoscope was used for endotracheal intubation.
Before reporting to Operation theatre a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected. On OT table pulse and systolic blood pressure was checked by non-invasive method. 18G cannula was passed and ECG was attached. A pillow was placed under the head to obtain classical sniffing position for intubation. All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg. Pre oxygenation was done with 100% oxygen for 3 mins. Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg. Laryngoscopy was started after 3 minutes by a qualified anesthetist. Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3minutes after intubation. All this information was recorded on a Proforma.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Punjab
-
Jhelum, Punjab, Pakistan, 49600
- CMH
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Both Male and Female
- Age between 18 to 70
- ASA I and II males and females.
- Malampatti I and II.
- Hemodynamically stable, no known ischemic heart disease and no history of hypertension.
- Nil per oral for at least 6 hours.
Exclusion Criteria:
- Non consenting patient.
- ASA III, IV or V patient.
- Malampati III or IV.
- Cervical instability
- Thyromental distance of less than 6cm, inter incisor distance of less than 3cm.
- Known case of hypertension and ischemic heart disease.
- Pregnant female.
- Body mass index of more than 30.
- Patients of oropharyngeal surgery.
- Unable to Intubate in less than 1 minute.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: GROUP A
Macintosh laryngoscope was used for endotracheal intubation.
|
Before reporting to Operation theatre, a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected.
On OT table pulse and systolic blood pressure was checked by non-invasive method.
18G cannula was passed and ECG was attached.
A pillow was placed under the head to obtain classical sniffing position for intubation.
All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg.
Pre oxygenation was done with 100% oxygen for 3 mins.
Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg.
Laryngoscopy was started after 3 minutes by a qualified anesthetist.
Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
|
Eksperymentalny: GROUP B
McCoy laryngoscope was used for endotracheal intubation.
|
Before reporting to Operation theatre, a detailed pre anesthesia assessment was done in all patients, all necessary laboratory investigations were collected.
On OT table pulse and systolic blood pressure was checked by non-invasive method.
18G cannula was passed and ECG was attached.
A pillow was placed under the head to obtain classical sniffing position for intubation.
All the patients were pre medicated with injection midazolam 0.08mg/kg, injection nalbuphine 0.1 mg/kg, injection dexamethasone 0.08mg/kg and injection metoclopramide 0.1 mg/kg.
Pre oxygenation was done with 100% oxygen for 3 mins.
Induction was done with injection propofol2 mg/kg, muscle relaxation achieved with injection atracurium 0.5mg/kg.
Laryngoscopy was started after 3 minutes by a qualified anesthetist.
Pulse and systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Effect on the pulse of intubation with Macintosh and McCoy laryngoscope
Ramy czasowe: After Laryngoscopy, pulse was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
|
To measure hemodynamic changes (i.e.
pulse) of intubation with Macintosh and McCoy laryngoscope
|
After Laryngoscopy, pulse was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation.
|
Effect on the systolic blood pressure of intubation with Macintosh and McCoy laryngoscope
Ramy czasowe: After Laryngoscopy, systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation
|
To measure hemodynamic changes (i.e.
systolic blood pressure) of intubation with Macintosh and McCoy
|
After Laryngoscopy, systolic blood pressure was recorded by non-invasive measures before laryngoscopy and at 30 seconds, 2 and 3 minutes after intubation
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 11112021
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Tracheal Intubation
-
Montefiore Medical CenterM.D. Anderson Cancer Center; The University of Texas Health Science Center,...Wycofane