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

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.

Study Overview

• Status: Recruiting
• Conditions: Obese Patients; Adjustable Headrests; Ventilation Function
• Intervention / Treatment: Other: the adjustable headrest group; Other: the supine head-lateral position group; Other: the supine head-straight position group

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: NaLi, MD; Phone Number: +862763490107; Email: lina@hbfy.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Maternal and Child Health Hospital of Hubei Province
      • Contact: Na Li, MD; Phone Number: +862763490107; Email: lina@hbfy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the adjustable headrest group: placing an adjustable pillows on the head; 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 adjustable headrest group: placing an adjustable pillows on the patient's head to align the patient's external auditory canal horizontally with the sternum
Active Comparator: the supine head-lateral position group; 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-lateral position group: during the perioperative period, keep the patient's head tilted to the left or right
Placebo Comparator: the supine head-straight position group; the supine head-straight position group: during the perioperative period, keep the patient's head upright	Other: the supine head-straight position group; the supine head-straight position group: during the perioperative period, keep the patient's head upright

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The time of entering the daytime operating room, intraoperative period, 1 minute after the patient wakes up

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Hubei Province
• Investigators: Principal Investigator: Na Li NaLi, MD, Maternal and Child Health Hospital of Hubei Province

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): February 22, 2026
• Study Completion (Estimated): September 22, 2026

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: MCHH_010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No