A Study on Application of Adjustable Headrest in Painless Curettage Surgery for Overweight and Obese Patients

NCT06929000 | Recruiting DMC

• 1 other identifier: MCHH_010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Incidence of hypoxemia

  Incidence of hypoxemia will be recorded after anesthesia induction

  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)

  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

  The time of entering the daytime operating room, intraoperative period, 1 minute after the patient wakes up

Study Arms (3)

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

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

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

Other: the supine head-straight position group

Interventions

the supine head-lateral position group OTHER

the supine head-lateral position group: during the perioperative period, keep the patient's head tilted to the left or right

the supine head-lateral position group

the adjustable headrest group OTHER

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 adjustable headrest group: placing an adjustable pillows on the head

the supine head-straight position group OTHER

the supine head-straight position group: during the perioperative period, keep the patient's head upright

the supine head-straight position group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Abnormal lung function or respiratory system diseases
• Airway obstruction or respiratory malformation
• cervical spondylosis
• psychiatric disorders

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

RECRUITING

Study Officials

• Na Li NaLi, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NaLi, MD

CONTACT

+862763490107; lina@hbfy.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 15, 2025
• Study Start: February 25, 2025
• Primary Completion: February 22, 2026
• Study Completion (Estimated): September 22, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)