ClinicalTrials.gg
Status unknownNCT05964309Updated Jul 27, 2023

Pre-oxygenation in Sitting Position and Oxygen Reserve Index

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

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hypoxemia

Browse trials for

Keywords

  • Oxygen reserve index
  • Preoxygenation
  • Hypoxemia
  • Sitting position
03

In context

Hypoxia

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 →

Lead sponsor

Imam Abdulrahman Bin Faisal University is the lead sponsor of 90 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Significant cardiac or pulmonary disease.
  • Anticipated difficult intubation.
  • History of seizures.
  • BMI 30kg/m2 or more.
  • Smoking.
  • Anemia.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Supine group(Control group)

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

    Other: supine group

  • Experimental
    sitting 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

Interventions

  • Othersupine 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

  • Othersitting group

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

06

What researchers measure

Primary outcomes

  1. Oxygen reserve index (ORI)alarming time

    time from intubation till ORI alarm in minutes

    Time frame: baseline, immediately after intubation, ORI warning alarm

Secondary outcomes

  1. 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

  2. Maximum Oxygen Reserve

    arterial oxygen tension (PaO2) after completion of pre-oxygenation

    Time frame: Baseline, immediately after preoxygenation

07

Study locations

1 site
  • King Fahd University Hospital
    Khobar, Eastern Province 34445, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2023
First posted
Jul 27, 2023
StartEst.
Sep 2023
Primary completionEst.
Sep 2024
CompletionEst.
Nov 2024
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05964309
Lead sponsor
Imam Abdulrahman Bin Faisal University
Responsible party
Roshdi R Almetwalli (Professor, Imam Abdulrahman Bin Faisal University) — Principal investigator
First posted
Jul 27, 2023
Start date
Sep 2023 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Jul 27, 2023

Study contacts

Roshdi M Almetwalli, MD
Contact
rmetwalli@iau.edu.sa
009660138966666 ext. 1486
Hitham MA Elsayed, MD
Contact
Himsayed@iau.edu.sa
009660138966666 ext. 1486

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion