Head Elevation During Pre-oxygenation Can Delay Desaturation Time

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05688722
Collaborator
(none)
56
1
4
2
28.4

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Supine position
  • Procedure: 20 degree head elevation position
  • Procedure: 30 degree head elevation position
  • Procedure: 45 degree head elevation position
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients were divided into 4 groups by random sampling each with different interventionPatients were divided into 4 groups by random sampling each with different intervention
Masking:
Single (Participant)
Masking Description:
The care provider and investigator were not blinded.
Primary Purpose:
Treatment
Official Title:
Head Elevation During Pre-oxygenation Can Delay Desaturation Time in Indonesian Patients
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
May 31, 2021
Actual Study Completion Date :
May 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Desaturation time [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cipto Mangunkusumo Central National Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ratna Farida Soenarto, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT05688722
Other Study ID Numbers:
  • IndonesiaUAnes913
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ratna Farida Soenarto, Principal Investigator, Indonesia University

Study Results

No Results Posted as of Jan 18, 2023