SurgeryNCT05688722
Head Elevation During Pre-oxygenation Can Delay Desaturation Time
A study testing Supine position, 20 degree head elevation position and 30 degree head elevation position in people with Surgery and Desaturation of Blood, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgery, Desaturation of Blood, Apnea
- What is being tested?
- Supine position, 20 degree head elevation position and 30 degree head elevation position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- undergo endotracheal intubation with general anesthesia for elective surgery
- aged 18-60 years old
- ASA physical status 1-2 preoperatively
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Head Elevation During Pre-oxygenation Can Delay Desaturation Time in Indonesian Patients
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
Read the detailed description
Preoxygenation anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation with head elevation 20°, 30° and 45° and conventional position to the time of desaturation before endotracheal intubation in patients undergoing general anesthesia. This was a randomized clinical trial of 56 patients, divided into four groups (conventional or 0° head elevation group, 20° head elevation group, 30° head elevation and 45° head elevation group). All subject was preoxygenated for 3 minutes with 100% oxygen. Induction of anesthesia was started with fentanyl, propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes. There was a significant difference in mean desaturation time among the four groups (p = 0.011). The most significant different was in 45o head elevation group (p < 0.05). . In patients undergoing general anesthesia, pre-oxygenation with head elevation 20°, 30° and 45° slows down the time for desaturation before endotracheal intubation compared to the conventional position. The 45° head elevation has the best result.
- Conditions
- Surgery, Desaturation of Blood, Apnea
- Being tested
- Supine position, 20 degree head elevation position, 30 degree head elevation position, 45 degree head elevation position
- Keywords
- preoxygenation, head elevation, desaturation, apnea
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine positionProcedure or surgery
Patients preoxygenated in supine position before endotracheal intubation
20 degree head elevation positionProcedure or surgery
Patients preoxygenated in 20 degree head elevation position before endotracheal intubation
30 degree head elevation positionProcedure or surgery
Patients preoxygenated in 30 degree head elevation position before endotracheal intubation
45 degree head elevation positionProcedure or surgery
Patients preoxygenated in 45 degree head elevation position before endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patient positioned in supine conventional position Receives: Procedure: Supine position |
| 20 degree head elevation | Active comparator | Patient positioned in 20 degree head elevation position Receives: Procedure: 20 degree head elevation position |
| 30 degree head elevation | Active comparator | Patient positioned in 30 degree head elevation position Receives: Procedure: 30 degree head elevation position |
| 45 degree head elevation | Active comparator | Patient positioned in 45 degree head elevation position Receives: Procedure: 45 degree head elevation position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation time
Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes
Measured: Right after induction until reach oxygen saturation 93% or 5 minutes time limit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Apr 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were divided into 4 groups by random sampling each with different intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ratna Farida Soenarto, Universitas Indonesia
- Investigators
- Ratna F Soenarto, Consultant, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688722
- Sponsor's protocol ID
- IndonesiaUAnes913
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Elevation During Pre-oxygenation Can Delay Desaturation Time in Indonesian Patients
- ClinicalTrials.gov ID
- NCT05688722
- Acronym / sponsor ID
- IndonesiaUAnes913
- Conditions
- Surgery, Desaturation of Blood, Apnea
- Keywords
- preoxygenation, head elevation, desaturation, apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Preoxygenation anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation with head elevation 20°, 30° and 45° and conventional position to the time of desaturation before endotracheal intubation in patients undergoing general anesthesia. This was a randomized clinical trial of 56 patients, divided into four groups (conventional or 0° head elevation group, 20° head elevation group, 30° head elevation and 45° head elevation group). All subject was preoxygenated for 3 minutes with 100% oxygen. Induction of anesthesia was started with fentanyl, propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes. There was a significant difference in mean desaturation time among the four groups (p = 0.011). The most significant different was in 45o head elevation group (p < 0.05). . In patients undergoing general anesthesia, pre-oxygenation with head elevation 20°, 30° and 45° slows down the time for desaturation before endotracheal intubation compared to the conventional position. The 45° head elevation has the best result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Patients were divided into 4 groups by random sampling each with different intervention
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Supine positionPatient positioned in supine conventional position |
| 20 degree head elevation | Active comparator | Procedure: 20 degree head elevation positionPatient positioned in 20 degree head elevation position |
| 30 degree head elevation | Active comparator | Procedure: 30 degree head elevation positionPatient positioned in 30 degree head elevation position |
| 45 degree head elevation | Active comparator | Procedure: 45 degree head elevation positionPatient positioned in 45 degree head elevation position |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- undergo endotracheal intubation with general anesthesia for elective surgery
- aged 18-60 years old
- ASA physical status 1-2 preoperatively
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine positionPatients preoxygenated in supine position before endotracheal intubation | Procedure or surgery | Control |
| 20 degree head elevation positionPatients preoxygenated in 20 degree head elevation position before endotracheal intubation | Procedure or surgery | 20 degree head elevation |
| 30 degree head elevation positionPatients preoxygenated in 30 degree head elevation position before endotracheal intubation | Procedure or surgery | 30 degree head elevation |
| 45 degree head elevation positionPatients preoxygenated in 45 degree head elevation position before endotracheal intubation | Procedure or surgery | 45 degree head elevation |
Primary outcome
Desaturation time
Time frame: Right after induction until reach oxygen saturation 93% or 5 minutes time limit
Time was recorded from the start of induction until the oxygen saturation showed 93% or a time limit of 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratna F Soenarto, Consultant principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine position, 20 degree head elevation position and 30 degree head elevation position in people with Surgery and Desaturation of Blood, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desaturation time (time frame: Right after induction until reach oxygen saturation 93% or 5 minutes time limit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023; AzTrials last refreshed its copy on 28 Oct 2026.