Adjustable HeadrestsNCT06929000
A Study on Application of Adjustable Headrest in Painless Curettage Surgery for Overweight and Obese Patients
A study testing the supine head-lateral position group, the adjustable headrest group and the supine head-straight position group in people with Adjustable Headrests and Ventilation Function, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial summary
The aim of this study is to observe the effect of adjustable headrests on ventilation function in overweight and obese patients through clinical experiments, and to explore the impact on the incidence of hypoxemia during painless curettage in overweight and obese patients. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adjustable Headrests, Ventilation Function, Obese Patients
- What is being tested?
- the supine head-lateral position group, the adjustable headrest group and the supine head-straight position group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 22 Sep 2026
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who choose to have painless surgical abortion
- Body mass index greater than 24
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- competent to provide informed consent
Who cannot join
- Abnormal lung function or respiratory system diseases
- Airway obstruction or respiratory malformation
- cervical spondylosis
- psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000
Na Li, MD, +862763490107, lina@hbfy.com
About this study
Official title: A Study on Application of Adjustable Headrest in Painless Curettage Surgery for Overweight and Obese Patients: a Randomized Controlled Trial
The aim of this study is to observe the effect of adjustable headrests on ventilation function in overweight and obese patients through clinical experiments, and to explore the impact on the incidence of hypoxemia during painless curettage in overweight and obese patients.
Participants will be randomly allocated to three groups: the supine head-straight position group(Group A), the supine head-lateral position group(Group B), and the adjustable headrest group(Group C). These three groups of patients underwent painless curettage surgery in the daytime operating room and the occurrence of hypoxemia will be observed.
- Conditions
- Adjustable Headrests, Ventilation Function, Obese Patients
- Being tested
- the supine head-lateral position group, the adjustable headrest group, the supine head-straight position group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the supine head-lateral position groupOther
the supine head-lateral position group: during the perioperative period, keep the patient's head tilted to the left or right
the adjustable headrest groupOther
the adjustable headrest group: placing an adjustable pillows on the patient's head to align the patient's external auditory canal horizontally with the sternum
the supine head-straight position groupOther
the supine head-straight position group: during the perioperative period, keep the patient's head upright
| Study group | Role | What they receive |
|---|---|---|
| the adjustable headrest group: placing an adjustable pillows on the head | Experimental | the adjustable headrest group: placing an adjustable pillows on the patient's head to align the patient's external auditory canal horizontally with the sternum Receives: Other: the adjustable headrest group |
| the supine head-lateral position group | Active comparator | the supine head-lateral position group: during the perioperative period, keep the patient's head tilted to the left or right Receives: Other: the supine head-lateral position group |
| the supine head-straight position group | Placebo comparator | the supine head-straight position group: during the perioperative period, keep the patient's head upright Receives: Other: the supine head-straight position group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
Incidence of hypoxemia will be recorded after anesthesia induction
Measured: 1,2 and 3 minutes after anesthesia induction
Respiratory rate and oxygen saturation
Respiratory rate and oxygen saturation will be recorded at 4 time points, including the time of entering the daytime operating room(Time 0), 1 minute after anesthesia induction(Time 1), 2 minute after anesthesia induction(Time 2), 3 minute after anesthesia induction(Time 3), 1 minute after the patient wakes up(Time 4)
Measured: The time of entering the daytime operating room, intraoperative period., 1 minute after the patient wakes up
Secondary outcomes (1)
Heart rate and blood pressure
heart rate and blood pressure will be recorded at 4 time points, including the time of entering the daytime operating room(Time 0), 1 minute after anesthesia induction(Time 1), 2 minute after anesthesia induction(Time 2), 3 minute after anesthesia induction(Time 3), 1 minute after the patient wakes up(Time 4)
Measured: The time of entering the daytime operating room, intraoperative period, 1 minute after the patient wakes up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start25 Feb 2025
- Primary completion22 Feb 2026 (estimated)
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustable HeadrestsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Na Li NaLi, MD, Principal investigator, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929000
- Sponsor's protocol ID
- MCHH_010
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Application of Adjustable Headrest in Painless Curettage Surgery for Overweight and Obese Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06929000
- Acronym / sponsor ID
- MCHH_010
- Conditions
- Adjustable Headrests, Ventilation Function, Obese Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 22 Feb 2026 (estimated)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 15 Apr 2025 (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 aim of this study is to observe the effect of adjustable headrests on ventilation function in overweight and obese patients through clinical experiments, and to explore the impact on the incidence of hypoxemia during painless curettage in overweight and obese patients.
Participants will be randomly allocated to three groups: the supine head-straight position group(Group A), the supine head-lateral position group(Group B), and the adjustable headrest group(Group C). These three groups of patients underwent painless curettage surgery in the daytime operating room and the occurrence of hypoxemia will be observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the adjustable headrest group: placing an adjustable pillows on the head | Experimental | Other: the adjustable headrest groupthe adjustable headrest group: placing an adjustable pillows on the patient's head to align the patient's external auditory canal horizontally with the sternum |
| the supine head-lateral position group | Active comparator | Other: the supine head-lateral position groupthe supine head-lateral position group: during the perioperative period, keep the patient's head tilted to the left or right |
| the supine head-straight position group | Placebo comparator | Other: the supine head-straight position groupthe supine head-straight position group: during the perioperative period, keep the patient's head upright |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients who choose to have painless surgical abortion
- Body mass index greater than 24
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- competent to provide informed consent
Key exclusion criteria (4 listed)
- Abnormal lung function or respiratory system diseases
- Airway obstruction or respiratory malformation
- cervical spondylosis
- psychiatric disorders
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 |
|---|---|---|
| the supine head-lateral position groupthe supine head-lateral position group: during the perioperative period, keep the patient's head tilted to the left or right | Other | the supine head-lateral position group |
| the adjustable headrest groupthe adjustable headrest group: placing an adjustable pillows on the patient's head to align the patient's external auditory canal horizontally with the sternum | Other | the adjustable headrest group: placing an adjustable pillows on the head |
| the supine head-straight position groupthe supine head-straight position group: during the perioperative period, keep the patient's head upright | Other | the supine head-straight position group |
Primary outcome
Incidence of hypoxemia
Time frame: 1,2 and 3 minutes after anesthesia induction
Incidence of hypoxemia will be recorded after anesthesia induction
Respiratory rate and oxygen saturation
Time frame: The time of entering the daytime operating room, intraoperative period., 1 minute after the patient wakes up
Respiratory rate and oxygen saturation will be recorded at 4 time points, including the time of entering the daytime operating room(Time 0), 1 minute after anesthesia induction(Time 1), 2 minute after anesthesia induction(Time 2), 3 minute after anesthesia induction(Time 3), 1 minute after the patient wakes up(Time 4)
1 secondary outcome
Heart rate and blood pressure
Time frame: The time of entering the daytime operating room, intraoperative period, 1 minute after the patient wakes up
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 15 Apr 2025.
- Individual participant dataSharing planned: Yes
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.
Na Li NaLi, MD principal investigator
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the supine head-lateral position group, the adjustable headrest group and the supine head-straight position group in people with Adjustable Headrests and Ventilation Function, run by Maternal and Child Health Hospital of Hubei Province 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 4 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: looking for participants now, as of the sponsor's last update on 15 Apr 2025. 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. 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?
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 NaLi, MD (+862763490107, lina@hbfy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia (time frame: 1,2 and 3 minutes after anesthesia induction). 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?
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 15 Apr 2025.