Sedation in Non-intubated Diagnostic and Therapeutic ProceduresNCT07880002
Efficacy and Safety of Nasopharyngeal Tube During Sedation
A study testing nasopharyngeal tube and regular cannula in people with Sedation in Non-intubated Diagnostic and Therapeutic Procedures and Sedation, run by International Peace Maternity and Child Health Hospital.
Trial summary
The goal of this randomized controlled study is to determine whether nasopharyngeal tube oxygenation could increase the fraction of inspired oxygen compared with standard oxygen during a sedated procedure with spontaneous breathing. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Sedation in Non-intubated Diagnostic and Therapeutic Procedures, Sedation
- What is being tested?
- nasopharyngeal tube and regular cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-60 years
- Scheduled for elective sedated gynecological surgery (including uterine dilation and curettage)
- American Society of Anesthesiologists classification (ASA) ≤II
Who cannot join
- Body mass index ≥28 or <18.5
- Mallampati classification of IV
- History of nasal surgery or nasal abnormalities
- History of coagulation disorders or nose bleeding
- Diagnosed chronic obstructive pulmonary diseases
- Upper respiratory tract infection
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- Baseline pulse oximeter (SpO2) <95%
- Allergy to drugs used during the procedure
- Psychiatric disorder or inability to comply with study investigators
- Unwillingness to provide written informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study on the Efficacy and Safety of Nasopharyngeal Tube During Sedation
The goal of this randomized controlled study is to determine whether nasopharyngeal tube oxygenation could increase the fraction of inspired oxygen compared with standard oxygen during a sedated procedure with spontaneous breathing. The main question it aims to answer is:
- Does nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen without increasing adverse events, compared with regular nasal cannula during sedation? Researchers will compare nasopharyngeal tube to regular nasal cannula to see if nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen.
Participants will:
- Receive regular nasal cannula or nasopharyngeal tube
- Being tested
- nasopharyngeal tube, regular cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal tubeDevice
The nasopharyngeal tube is a soft lubricated wire-reinforced tube with an internal diameter of 2.5mm, and an outer diameter of 4 mm.
regular cannulaDevice
A regular nasal cannula is a common method to deliver oxygen.
| Study group | Role | What they receive |
|---|---|---|
| nasopharyngeal tube | Experimental | After sedation, participants in the nasopharyngeal tube intervention group were received oxygen by nasopharyngeal tube placement. Receives: Device: nasopharyngeal tube |
| regular cannula | Active comparator | After sedation, participants in the regular cannula intervention group were received oxygen by regular nasal cannula. Receives: Device: regular cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fraction of inspired oxygen
The primary outcome was the fraction of inspired oxygen (FiO₂) that was continuously measured using the same anesthesia machine during sedation.
Measured: Perioperatively
Secondary outcomes (2)
Other respiration related parameters
The fraction of expired oxygen (FeO₂), partial pressure of end-tidal carbon dioxide (PetCO₂), and respiratory rate (RR); hypoxia, open airway, suction, oxygen flow, mask, intubation.
Measured: Perioperatively
Adverse events
hypotension, bradycardia, mucosal injury, epistaxia, rhinalgia, nausea, cough
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation in Non-intubated Diagnostic and Therapeutic ProceduresStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880002
- Sponsor's protocol ID
- InternationalPMCHH
- Other IDs
- Shanghai Jiaotong University
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy and Safety of Nasopharyngeal Tube During Sedation
- ClinicalTrials.gov ID
- NCT07880002
- Acronym / sponsor ID
- InternationalPMCHH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
The goal of this randomized controlled study is to determine whether nasopharyngeal tube oxygenation could increase the fraction of inspired oxygen compared with standard oxygen during a sedated procedure with spontaneous breathing. The main question it aims to answer is:
- Does nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen without increasing adverse events, compared with regular nasal cannula during sedation? Researchers will compare nasopharyngeal tube to regular nasal cannula to see if nasopharyngeal tube oxygenation deliver higher fraction of inspired oxygen.
Participants will:
- Receive regular nasal cannula or nasopharyngeal tube
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasopharyngeal tube | Experimental | Device: nasopharyngeal tubeAfter sedation, participants in the nasopharyngeal tube intervention group were received oxygen by nasopharyngeal tube placement. |
| regular cannula | Active comparator | Device: regular cannulaAfter sedation, participants in the regular cannula intervention group were received oxygen by regular nasal cannula. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-60 years
- Scheduled for elective sedated gynecological surgery (including uterine dilation and curettage)
- American Society of Anesthesiologists classification (ASA) ≤II
Key exclusion criteria (10 listed)
- Body mass index ≥28 or <18.5
- Mallampati classification of IV
- History of nasal surgery or nasal abnormalities
- History of coagulation disorders or nose bleeding
- Diagnosed chronic obstructive pulmonary diseases
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 |
|---|---|---|
| nasopharyngeal tubeThe nasopharyngeal tube is a soft lubricated wire-reinforced tube with an internal diameter of 2.5mm, and an outer diameter of 4 mm. | Device | nasopharyngeal tube |
| regular cannulaA regular nasal cannula is a common method to deliver oxygen. | Device | regular cannula |
Primary outcome
The fraction of inspired oxygen
Time frame: Perioperatively
The primary outcome was the fraction of inspired oxygen (FiO₂) that was continuously measured using the same anesthesia machine during sedation.
2 secondary outcomes
Other respiration related parameters
Time frame: Perioperatively
Adverse events
Time frame: Perioperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing nasopharyngeal tube and regular cannula in people with Sedation in Non-intubated Diagnostic and Therapeutic Procedures and Sedation, run by International Peace Maternity and Child Health Hospital.
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 10 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zifeng Xu, Dr. (86-21-64070434, xuzf@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The fraction of inspired oxygen (time frame: Perioperatively). 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 19 Oct 2026.