Head Elevation During Pre-oxygenation Can Delay Desaturation Time

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

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

Study Overview

• Status: Completed
• Conditions: Apnea; Surgery; Desaturation of Blood
• Intervention / Treatment: Procedure: Supine position; Procedure: 20 degree head elevation position; Procedure: 30 degree head elevation position; Procedure: 45 degree head elevation position

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Patient positioned in supine conventional position	Procedure: Supine position; Patients preoxygenated in supine position before endotracheal intubation
Active Comparator: 20 degree head elevation; Patient positioned in 20 degree head elevation position	Procedure: 20 degree head elevation position; Patients preoxygenated in 20 degree head elevation position before endotracheal intubation
Active Comparator: 30 degree head elevation; Patient positioned in 30 degree head elevation position	Procedure: 30 degree head elevation position; Patients preoxygenated in 30 degree head elevation position before endotracheal intubation
Active Comparator: 45 degree head elevation; Patient positioned in 45 degree head elevation position	Procedure: 45 degree head elevation position; Patients preoxygenated in 45 degree head elevation position before endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Ratna F Soenarto, Consultant, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: preoxygenation; apnea; desaturation; head elevation
• Other Study ID Numbers: IndonesiaUAnes913

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No