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HypoxemiaNCT06459167

Position Intervention to Reduce Hypoxemia in Sedation Patients

A study testing The position adopted when patients undergoing procedure or surgery in people with Hypoxemia and Sedation Complication, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hypoxemia was defined as an SpO2 of < 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypoxemia, Sedation Complication, Emergencies
What is being tested?
The position adopted when patients undergoing procedure or surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,752 participants
Where
1 siteChina
Study dates
20 Jun 2024to 30 Jun 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with 18 years or older
  • Without obvious cardiovascular or pulmonary dysfunction
  • Scheduled to undergo procedure or surgery with sedation
  • Signed the informed consent form

Who cannot join

  • Preexisting bradycardia (heart rate <50 beats/min), hypotension (systolic blood pressure < 80mmHg), or hypoxemia (SpO2 < 90%);
  • Requiring supplemental chronic or intermittent oxygen therapy because of preexisting diseases
  • Preexisting diseases which unable to tolerate reduced SpO2 or Partial pressure of carbon dioxide in artery (PaCO2) diseases, such as severe cardiovascular and cerebrovascular diseases, intracranial hypertension or severe lung diseases;
  • Coagulation disorders or a tendency of nose bleeding;
  • Patients whose body position cannot be altered;
  • Participated in other intervention clinical studies in the past 3 months;
  • Other conditions deemed unsuitable for inclusion by the researcher;
  • Patients and guardians refused to participate in this trial.

Trial locations and contacts

1 site in 1 country.

Hui Ye, M.D. contact

8615267048716

yehui@zju.edu.cn

Xiangming Fang, M.D. contact

8613857161019

xmfang@zju.edu.cn

China1 site

  • The First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Hypoxemia was defined as an SpO2 of < 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple interventions by changing position to maintain patients' respiratory function can be more economical, convenient and safe.

Read the detailed description

Hypoxemia was defined as an SpO2 of < 90% for any duration. Failure to treat promptly can lead to hypoxemia, which may increase the risks of arrhythmia, nausea and vomiting, and cognitive dysfunction. Studies have shown that body position has a direct impact on respiratory function. In special environments, including outside the operating room where emergency airway management for critically ill and injured patients is needed, or in areas with limited medical resources like remote areas, adopting simple positional interventions to maintain patients' respiratory function can be more economical, convenient and safe. This study aims to conduct a prospective, multicenter, randomized controlled trial to observe the level of patients' oxygen saturation and the occurrence of hypoxemia under different body positions (supine and lateral positions), and its impact on prognosis, providing reliable evidence-based medical evidence for the prevention and treatment of complications in patients requiring airway management.

Being tested
The position adopted when patients undergoing procedure or surgery
Keywords
position, hypoxemia, sedation, emergency, upper airway
Medical subject headings
Hypoxia, Emergencies, Airway Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The position adopted when patients undergoing procedure or surgeryOther

    For patients requiring sedation for procedures or surgery, they are randomly assigned either to supine position or lateral position before they are sedated, and kept during procedure or surgery.

Study groups in NCT06459167
Study groupRoleWhat they receive
Group SExperimentalPatients needing sedation for procedure or surgery are assisted into supine position before they were sedated and kept during the procedure.
Receives: Other: The position adopted when patients undergoing procedure or surgery
Group LExperimentalPatients needing sedation for procedure or surgery are assisted into lateral position before they were sedated and kept the procedure.
Receives: Other: The position adopted when patients undergoing procedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The lowest SpO2

    The lowest SpO2 during sedation and procedures

    Measured: During procedure

  2. Use of airway interventions

    Use of airway interventions including increased inhaled O2, ventilated mask and endotracheal intubation

    Measured: During procedure

Secondary outcomes (6)

  1. The onset of when SpO2 dropped below 80%

    The onset of when SpO2 reached below 80%

    Measured: During procedure

  2. The onset of when SpO2 dropped below 70%

    The onset of when SpO2 reached below 70%

    Measured: During procedure

  3. The onset of respiratory adverse events

    The onset of respiratory adverse events including apnea, laryngospasm, aspiration due to regurgitation

    Measured: During procedure

  4. The onset of circulatory adverse events

    The onset of circulatory adverse events including hypotension, hypertension, bradycardia, tachycardia, new-onset arrhythmia with hemodynamically stable/instability, cardiac arrest, shock

    Measured: During procedure

  5. The onset of gastrointestinal adverse events

    The onset of gastrointestinal adverse events including nausea and vomiting, regurgitation

    Measured: During procedure

  6. The degree of operator satisfaction

    The degree of operator satisfaction regarding the performance, effectiveness, and experience of a procedure. A 10-point scale is used, 0 indicates complete dissatisfaction and 10 indicates complete satisfaction.

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start20 Jun 2024 (estimated)
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,752 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459167
Sponsor's protocol ID
Hypoxemia
Status last verified
Jun 2024
First submitted
24 May 2024
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Klare P, Huth R, Haller B, Huth M, Weber A, Schlag C, Reindl W, Schmid RM, von Delius S. Patient position and hypoxemia during propofol sedation for colonoscopy: a randomized trial. Endoscopy. 2015 Dec;47(12):1159-66. doi: 10.1055/s-0034-1392329. Epub 2015 Jun 30.

    PubMed 26126161

  • Ababneh O, Bsisu I, El-Share' AI, Alrabayah M, Qudaisat I, Alghanem S, Khreesha L, Ali AM, Rashdan M. Awake Nasal Fiberoptic Intubation in Lateral Position for Severely Obese Patients with Anticipated Difficult Airway: A Randomized Controlled Trial. Healthcare (Basel). 2023 Oct 24;11(21):2818. doi: 10.3390/healthcare11212818.

    PubMed 37957962

  • Edmark L, Kostova-Aherdan K, Enlund M, Hedenstierna G. Optimal oxygen concentration during induction of general anesthesia. Anesthesiology. 2003 Jan;98(1):28-33. doi: 10.1097/00000542-200301000-00008.

    PubMed 12502975

  • Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.

    PubMed 28487139

  • Wahdan AS, El-Refai NAR, Omar SH, Abdel Moneem SA, Mohamed MM, Hussien MM. Endotracheal intubation in patients undergoing open abdominal surgery in the lateral position: a comparison between the intubating video stylet and fiberoptic intubating bronchoscopy. Korean J Anesthesiol. 2021 Jun;74(3):234-241. doi: 10.4097/kja.20384. Epub 2020 Oct 19.

    PubMed 33070582

  • Leeb G, Auchus I, Law T, Bickler P, Feiner J, Hashi S, Monk E, Igaga E, Bernstein M, Chou YC, Hughes C, Schornack D, Lester J, Moore K Jr, Okunlola O, Fernandez J, Shmuylovich L, Lipnick M. The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigment. EBioMedicine. 2024 Apr;102:105051. doi: 10.1016/j.ebiom.2024.105051. Epub 2024 Mar 8.

    PubMed 38458110

  • Ye H, Chu LH, Xie GH, Hua YJ, Lou Y, Wang QH, Xu ZX, Tang MY, Wang BD, Hu HY, Ying J, Yu T, Wang HY, Wang Y, Ye ZJ, Bao XF, Wang MC, Chen LY, Wang XX, Zhang XB, Huang CS, Wang J, Lu YP, Luo FQ, Zhou W, Wang CG, Cheng H, Liu WJ, Luo J, Wu YQ, Li RR, Wang D, Hou LQ, Shi L, Zhang J, Wang K, Pi X, Zhou R, Yang QQ, Wan PL, Li H, Wu SJ, Song SW, Cui P, Shu L, Islam N, Fang XM. Effect of lateral versus supine positioning on hypoxaemia in sedated adults: multicentre randomised controlled trial. BMJ. 2025 Aug 19;390:e084539. doi: 10.1136/bmj-2025-084539.

    PubMed 40829895

Questions about this trial

What is this clinical trial studying?

A study testing The position adopted when patients undergoing procedure or surgery in people with Hypoxemia and Sedation Complication, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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 China. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hui Ye, M.D. (8615267048716, yehui@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The lowest SpO2 (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06459167, which also lists 7 linked publications.

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 14 Jun 2024.

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