Head Elevation During Pre-oxygenation Can Delay Desaturation Time

NCT05688722 | Completed DMC

• 1 other identifier: IndonesiaUAnes913
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Surgery; Desaturation of Blood; Apnea

Keywords

preoxygenation; head elevation; desaturation; apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Control

PLACEBO COMPARATOR

Patient positioned in supine conventional position

Procedure: Supine position

20 degree head elevation

ACTIVE COMPARATOR

Patient positioned in 20 degree head elevation position

Procedure: 20 degree head elevation position

30 degree head elevation

ACTIVE COMPARATOR

Patient positioned in 30 degree head elevation position

Procedure: 30 degree head elevation position

45 degree head elevation

ACTIVE COMPARATOR

Patient positioned in 45 degree head elevation position

Procedure: 45 degree head elevation position

Interventions

Supine position PROCEDURE

Patients preoxygenated in supine position before endotracheal intubation

Control

20 degree head elevation position PROCEDURE

Patients preoxygenated in 20 degree head elevation position before endotracheal intubation

20 degree head elevation

30 degree head elevation position PROCEDURE

Patients preoxygenated in 30 degree head elevation position before endotracheal intubation

30 degree head elevation

45 degree head elevation position PROCEDURE

Patients preoxygenated in 45 degree head elevation position before endotracheal intubation

45 degree head elevation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• undergo endotracheal intubation with general anesthesia for elective surgery
• aged 18-60 years old
• ASA physical status 1-2 preoperatively

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Apnea

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ratna F Soenarto, Consultant

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The care provider and investigator were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients were divided into 4 groups by random sampling each with different intervention

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: April 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

ID (1)