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Pre-oxygenation in Sitting Position and Oxygen Reserve Index

Primary Purpose

Hypoxemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
supine group
sitting group
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxemia focused on measuring Oxygen reserve index, Preoxygenation, Hypoxemia, Sitting position

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Elective surgery Age 18-60 years General Anesthesia with endotracheal intubation Exclusion Criteria: Significant cardiac or pulmonary disease. Anticipated difficult intubation. History of seizures. BMI 30kg/m2 or more. Smoking. Anemia.

Sites / Locations

  • King Fahd University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Supine group(Control group)

sitting group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Oxygen reserve index (ORI)alarming time
time from intubation till ORI alarm in minutes

Secondary Outcome Measures

safe apnea time
time from intubation till Oxygen saturation (SpO2) drop to 94%.
Maximum Oxygen Reserve
arterial oxygen tension (PaO2) after completion of pre-oxygenation

Full Information

First Posted
June 11, 2023
Last Updated
July 26, 2023
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT05964309
Brief Title
Pre-oxygenation in Sitting Position and Oxygen Reserve Index
Official Title
Effect of Preoxygenation in Sitting Position on The Oxygen Reserve Index (ORI) Alarm Time as Early Predictor of Impending Hypoxemia During Prolonged Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Introduction Pre oxygenation with high fraction of inspired oxygen is not only recommended before anesthesia induction and intubation but also to delay apnea induced hypoxemia in a variety of airway management and patients with limited oxygen reserve. As well as, to prolong the duration of apneic oxygenation in some airway interventions. Several methods have been used to improve the efficiency of pre oxygenation with controversial outcome. One of these methods is the performance of pre oxygenation in head up position. During anesthetic management, pulse oximeter has been considered as valuable noninvasive tool for monitoring of patient oxygen saturation (SpO2%). However, the relationship between the oxygen saturation (SpO2%) and the arterial partial pressure of oxygen (PaO2) restricts the pulse oximeter monitoring of patient oxygenation due to the sigmoidal pattern of this relation, as small changes only in SpO2% occur with increase in arterial oxygen tension above 80 mmHg., Therefore, when oxygen is provided, SpO2 remains 100% over a wide range of PaO2 (>80 mmHg) So It does not reflect the degree of hyperoxia during oxygen supplementation. On the other hand, when PaO2 is falling, the SpO2 may remain 100% until the PaO2 falls below approximately 80 mm Hg. Thus, it does not predict the onset of hypoxia in an apneic patient. Oxygen reserve index (ORI) is a non-invasive real time non-unit scale between 0.00 and 1.00, which reflects the level of venous blood oxygen saturation (SvO2). When the patient is breathing room air ORI is 0.00, With oxygen supplementation, after SpO2 reaches its plateau of 100%, SvO2 continues rising as PaO2 increasing, and at PaO2 200mmHg usually ORI reaches a plateau. Hence ORI will serve to indicate PaO2 trends (rising or falling) in the range of 100-200 mmHg), so it will reflect the range of moderate hyperoxia (PaO2 ranging from 100 to 200 mmHg) during oxygen supply and, on the other hand, it will predict impending desaturation ahead of standard pulse oximetry during safe prolonged apnea technique in surgical patients at high risk. Our study aims at assessment of the effect of pre oxygenation in sitting position on the ORI warning time for impending de-saturation during safe prolonged apnea techniques. Methodology After approval of Institution Review Board and obtaining written informed consent from all participants, this prospective randomized controlled study will be conducted at King Fahd University hospital. Written, informed consent will be obtained from 56 illegible participants scheduled for elective surgery with planned general anesthesia with endotracheal intubation and invasive blood pressure monitoring (arterial line). According to the head position during pre-oxygenation, participants will be randomly allocated via a computer-generated sequence into two groups; supine group (flat head position- n=28) and sitting group (90 degree head up position- n=28). In the operation room standard monitoring will be applied. ORI sensor (Masimo RD lite) will be attached to the participant finger. After recording the baseline vital signs, pre oxygenation in the three groups will be started by asking participants to spontaneously breath 100% oxygen via a well fitted face mask for 3 minutes, with rising of end-tidal fraction of oxygen (EtO2) to at least 0.9 and/or ORI to a plateau value. Rapid sequence induction and intubation using fentanyl, propofol, and succinylcholine will be performed with the aid of video assisted laryngoscope. The appropriate position of the endotracheal tube will be confirmed with direct vision and, will be disconnected from the breathing circuit (to prevent oxygenation while the patient is apneic) and exposed to the room air until SpO2 decreased to 94% then tube will be connected to the breathing circuit. Thereafter ventilator setting and anesthetic management will be according to the decision of the anesthesiologist assigned for patient care at this operative theater. ORI, SpO2 and PaO2 data were measured at four specific times (1) baseline (2) at the end of pre-oxygenation (3) at ORI alarm (4) when SpO2 reached 94%. The participant will be excluded from the study if he has failed pre oxygenation (EtO2 < 0.9 and/or ORI does not reach a plateau value after 3 min. pre oxygenation. Statistical analysis If the difference between the mean ORI alarm time in the sitting group and the supine group is assumed to be 25 seconds, and a pooled standard deviation of 33 seconds., 28 participants in each group with a total of 56 participant would be an appropriate sample size to provide a significance of 5% and a power of 80%. Data that will be normally distributed will be compared using t-test. Whereas Mann-Whitney test will be used to compare data with abnormal distribution. Fisher's exact test or Chi square test will be used to compare categorical data or gender ratio. Probability (p-value) less than 0.05 will be considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
Oxygen reserve index, Preoxygenation, Hypoxemia, Sitting position

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supine group(Control group)
Arm Type
Experimental
Arm Description
Supine group (flat head position- n=28) during pre-oxygenation patients will be in supine position
Arm Title
sitting group
Arm Type
Experimental
Arm Description
Sitting position (90 degree head up position- n=28) during pre-oxygenation patients will be in 90 degree head up position
Intervention Type
Other
Intervention Name(s)
supine group
Other Intervention Name(s)
control group
Intervention Description
after pre-oxygenation in supine position general anesthesia will be established then apnea alarm time will be recorded and compared with other group
Intervention Type
Other
Intervention Name(s)
sitting group
Intervention Description
after pre-oxygenation in sitting position general anesthesia will be established then apnea alarm time will be recorded and compared with other group
Primary Outcome Measure Information:
Title
Oxygen reserve index (ORI)alarming time
Description
time from intubation till ORI alarm in minutes
Time Frame
baseline, immediately after intubation, ORI warning alarm
Secondary Outcome Measure Information:
Title
safe apnea time
Description
time from intubation till Oxygen saturation (SpO2) drop to 94%.
Time Frame
baseline, immediately after intubation, when SpO2 % drop to 94% assessed in first 10 minutes after induction of general anesthesia
Title
Maximum Oxygen Reserve
Description
arterial oxygen tension (PaO2) after completion of pre-oxygenation
Time Frame
Baseline, immediately after preoxygenation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elective surgery Age 18-60 years General Anesthesia with endotracheal intubation Exclusion Criteria: Significant cardiac or pulmonary disease. Anticipated difficult intubation. History of seizures. BMI 30kg/m2 or more. Smoking. Anemia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roshdi M Almetwalli, MD
Phone
009660138966666
Ext
1486
Email
rmetwalli@iau.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Hitham MA Elsayed, MD
Phone
009660138966666
Ext
1486
Email
Himsayed@iau.edu.sa
Facility Information:
Facility Name
King Fahd University Hospital
City
Khobar
State/Province
Eastern
ZIP/Postal Code
34445
Country
Saudi Arabia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hitham MA Elsyed, MD
Phone
009660138966666
Ext
1486
Email
HIMelsayed@iau.edu.sa
First Name & Middle Initial & Last Name & Degree
Roshdi M Almetwalli, MD
Phone
009660138966666
Ext
1486
Email
rmetwalli@iau.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre-oxygenation in Sitting Position and Oxygen Reserve Index

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