Pre-oxygenation in Sitting Position and Oxygen Reserve Index

NCT05964309 | Unknown DMC

• 1 other identifier: IRB-2022-01-446
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, controlled and randomized study aims at comparing the effect of position on the oxygen reserve index alarm time which is considered as predictor of hypoxemia in prolonged apnea which might be faced during general anesthesia (GA) in several situations such as the time from induction of anesthesia till endotracheal intubation. participants will be divided into two groups; supine (n=38) and sitting group (n=38) both group will undergo elective procedures under GA and endotracheal intubation

Conditions

Hypoxemia

Keywords

Oxygen reserve index; Preoxygenation; Hypoxemia; Sitting position

Outcome Measures

Primary Outcomes (1)

• Oxygen reserve index (ORI)alarming time

  time from intubation till ORI alarm in minutes

  baseline, immediately after intubation, ORI warning alarm

Secondary Outcomes (2)

• safe apnea time

  baseline, immediately after intubation, when SpO2 % drop to 94% assessed in first 10 minutes after induction of general anesthesia

• Maximum Oxygen Reserve

  Baseline, immediately after preoxygenation

Study Arms (2)

Supine group(Control group)

EXPERIMENTAL

Supine group (flat head position- n=28) during pre-oxygenation patients will be in supine position

Other: supine group

sitting group

EXPERIMENTAL

Sitting position (90 degree head up position- n=28) during pre-oxygenation patients will be in 90 degree head up position

Other: sitting group

Interventions

supine group OTHER

after pre-oxygenation in supine position general anesthesia will be established then apnea alarm time will be recorded and compared with other group

Also known as: control group

Supine group(Control group)

sitting group OTHER

after pre-oxygenation in sitting position general anesthesia will be established then apnea alarm time will be recorded and compared with other group

sitting group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective surgery
• Age 18-60 years
• General Anesthesia with endotracheal intubation

You may not qualify if:

• Significant cardiac or pulmonary disease.
• Anticipated difficult intubation.
• History of seizures.
• BMI 30kg/m2 or more.
• Smoking.
• Anemia.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahd University Hospital

Khobar, Eastern Province, 34445, Saudi Arabia

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Roshdi M Almetwalli, MD

CONTACT

009660138966666; rmetwalli@iau.edu.sa

Hitham MA Elsayed, MD

CONTACT

009660138966666; Himsayed@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)