- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05133375
Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
Comparison of Hemodynamic Changes of Tracheal Intubation With McCoy and Macintosh Laryngoscopes
Přehled studie
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Punjab
-
Jhelum, Punjab, Pákistán, 49600
- CMH
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effect on the pulse of intubation with Macintosh and McCoy laryngoscope
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 11112021
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