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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05688722
Other study ID # IndonesiaUAnes913
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date May 31, 2021

Study information

Verified date January 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized-controlled trial study comparing the association between several degree of head elevation and conventional position during pre-oxygenation to desaturation time in patients undergo endotracheal intubation with general anesthesia


Description:

Preoxygenation anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation with head elevation 20°, 30° and 45° and conventional position to the time of desaturation before endotracheal intubation in patients undergoing general anesthesia. This was a randomized clinical trial of 56 patients, divided into four groups (conventional or 0° head elevation group, 20° head elevation group, 30° head elevation and 45° head elevation group). All subject was preoxygenated for 3 minutes with 100% oxygen. Induction of anesthesia was started with fentanyl, propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes. There was a significant difference in mean desaturation time among the four groups (p = 0.011). The most significant different was in 45o head elevation group (p < 0.05). . In patients undergoing general anesthesia, pre-oxygenation with head elevation 20°, 30° and 45° slows down the time for desaturation before endotracheal intubation compared to the conventional position. The 45° head elevation has the best result.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - undergo endotracheal intubation with general anesthesia for elective surgery - aged 18-60 years old - ASA physical status 1-2 preoperatively Exclusion Criteria: - Patients with difficult airway, cardiopulmonary disease, anemia, grade II obesity, pregnant, history of hypersensitivity to induction agents - Patients did not give consent to follow the study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Supine position
Patients preoxygenated in supine position before endotracheal intubation
20 degree head elevation position
Patients preoxygenated in 20 degree head elevation position before endotracheal intubation
30 degree head elevation position
Patients preoxygenated in 30 degree head elevation position before endotracheal intubation
45 degree head elevation position
Patients preoxygenated in 45 degree head elevation position before endotracheal intubation

Locations

Country Name City State
Indonesia Cipto Mangunkusumo Central National Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Desaturation time Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes Right after induction until reach oxygen saturation 93% or 5 minutes time limit
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