Head Elevation During Pre-oxygenation Can Delay Desaturation Time

NCT ID: NCT05688722

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-05-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Surgery Desaturation of Blood Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients were divided into 4 groups by random sampling each with different intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The care provider and investigator were not blinded.

Study Groups

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Control

Patient positioned in supine conventional position

Group Type PLACEBO_COMPARATOR

Supine position

Intervention Type PROCEDURE

Patients preoxygenated in supine position before endotracheal intubation

20 degree head elevation

Patient positioned in 20 degree head elevation position

Group Type ACTIVE_COMPARATOR

20 degree head elevation position

Intervention Type PROCEDURE

Patients preoxygenated in 20 degree head elevation position before endotracheal intubation

30 degree head elevation

Patient positioned in 30 degree head elevation position

Group Type ACTIVE_COMPARATOR

30 degree head elevation position

Intervention Type PROCEDURE

Patients preoxygenated in 30 degree head elevation position before endotracheal intubation

45 degree head elevation

Patient positioned in 45 degree head elevation position

Group Type ACTIVE_COMPARATOR

45 degree head elevation position

Intervention Type PROCEDURE

Patients preoxygenated in 45 degree head elevation position before endotracheal intubation

Interventions

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Supine position

Patients preoxygenated in supine position before endotracheal intubation

Intervention Type PROCEDURE

20 degree head elevation position

Patients preoxygenated in 20 degree head elevation position before endotracheal intubation

Intervention Type PROCEDURE

30 degree head elevation position

Patients preoxygenated in 30 degree head elevation position before endotracheal intubation

Intervention Type PROCEDURE

45 degree head elevation position

Patients preoxygenated in 45 degree head elevation position before endotracheal intubation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Ratna Farida Soenarto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ratna F Soenarto, Consultant

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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IndonesiaUAnes913

Identifier Type: -

Identifier Source: org_study_id

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