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Completed

NCT Number: NCT05688722

Head Elevation During Pre-oxygenation Can Delay Desaturation Time

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supine position

Procedure

Patients preoxygenated in supine position before endotracheal intubation

20 degree head elevation position

Procedure

Patients preoxygenated in 20 degree head elevation position before endotracheal intubation

30 degree head elevation position

Procedure

Patients preoxygenated in 30 degree head elevation position before endotracheal intubation

45 degree head elevation position

Procedure

Patients preoxygenated in 45 degree head elevation position before endotracheal intubation

Primary outcomes

  1. Desaturation time

    Time frame: Right after induction until reach oxygen saturation 93% or 5 minutes time limit

    Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Head Elevation During Pre-oxygenation Can Delay Desaturation Time in Indonesian Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2023
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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