An interventional study of supine group and sitting group in Hypoxemia, sponsored by Imam Abdulrahman Bin Faisal University. Status unknown at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Other
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
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.
1,245 studies on the registry are indexed under Hypoxia; 239 are open to participants now.
This study's planned enrollment of 56 is above the median of 45 across 864 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Imam Abdulrahman Bin Faisal University is the lead sponsor of 90 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Supine group (flat head position- n=28) during pre-oxygenation patients will be in supine position
Other: supine group
Sitting position (90 degree head up position- n=28) during pre-oxygenation patients will be in 90 degree head up position
Other: sitting group
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
after pre-oxygenation in sitting position general anesthesia will be established then apnea alarm time will be recorded and compared with other group
Oxygen reserve index (ORI)alarming time
time from intubation till ORI alarm in minutes
Time frame: baseline, immediately after intubation, ORI warning alarm
safe apnea time
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
Maximum Oxygen Reserve
arterial oxygen tension (PaO2) after completion of pre-oxygenation
Time frame: Baseline, immediately after preoxygenation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2023; primary completion for Sep 2024, 12 months later.
Of 374 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 406 studies reached it within 13 months; a quarter within 4 and three quarters within 29.
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This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Imam Abdulrahman Bin Faisal University