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Postoperative HypoxemiaNCT07587970

Effect of Different Body Positions on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy

A study testing lateral decubitus head-up position (LH group), supine head-up position (SH group) and standard lateral decubitus position group (SL group) in people with Postoperative Hypoxemia, run by General Hospital of Ningxia Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Through a multicenter, three-arm randomized controlled trial design, this study aimed to compare the effects of three positioning strategies-side-lying with elevated head position, supine with elevated head position, and standard side-lying position-on the incidence of hypoxemia during the recovery phase in patients… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Hypoxemia
What is being tested?
lateral decubitus head-up position (LH group), supine head-up position (SH group) and standard lateral decubitus position group (SL group)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,617 participants
Where
1 siteChina
Study dates
8 May 2026to 31 Jan 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status classification I-III.
  • Scheduled for combined painless esophagogastroduodenoscopy/colonoscopy or either of the two procedures.
  • Ability to understand the study protocol and provide written informed consent.
  • A broad set of inclusion criteria was adopted to enroll a patient population that better reflects routine clinical practice. The study aimed to enhance the generalizability of the findings by including patients with various comorbidities, such as preprocedural hypoxemia (room-air SpO₂ ≤ 90%), history of pulmonary surgery, obstructive sleep apnea (OSA), and other pulmonary conditions (including asthma, COPD, chronic bronchitis, emphysema, and pulmonary bullae).

Who cannot join

  • Severe cardiovascular or cerebrovascular diseases.
  • Pregnant patients.
  • History of hypersensitivity to ciprofol.
  • Withdrawal Criteria:
  • Endotracheal intubation required during the procedure.
  • Voluntary withdrawal requested by the patient or their legal representative.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

xiaoyong wei, Master's degree contact

86-951-674-3252

weixy9912@126.com

China1 site, 1 recruiting
  • General hospital of Ningxia medical university, Yinchuan, Ningxia

    Yinchuan, Ningxia, 750001

    xiaoyong wei, 86-951-674-3252, weixy9912@126.cm

    Recruiting

Other trials in China

About this study

Official title: Effects of Lateral Decubitus Head-up Position, Supine Head-up Position, and Standard Lateral Decubitus Position on Hypoxemia During Recovery in Patients Undergoing Painless Gastroscopy and Colonoscopy: A Multicenter, Three-arm Randomized Controlled Trial

Through a multicenter, three-arm randomized controlled trial design, this study aimed to compare the effects of three positioning strategies-side-lying with elevated head position, supine with elevated head position, and standard side-lying position-on the incidence of hypoxemia during the recovery phase in patients undergoing painless gastroscopy and colonoscopy. The goal was to provide clinicians with a simple, non-invasive, and cost-effective optimization strategy.

Read the detailed description

Painless gastroscopy and colonoscopy have become the gold standard for screening and diagnosing gastrointestinal diseases due to their high patient comfort and excellent compliance rates, with their clinical application expanding annually. This procedure is performed under intravenous general anesthesia to achieve painlessness; however, anesthetic agents exert inhibitory effects on the patient's respiratory center. Additionally, the procedural manipulation causes irritation to the airways and gastrointestinal tract, leading to a high incidence of hypoxemia during the postoperative recovery phase-the most common respiratory adverse event associated with painless gastroscopy and colonoscopy. Mild cases may prolong patient recovery time, while severe cases can result in serious complications such as hypoxic brain injury or cardiac arrest, directly compromising patient safety and healthcare experience.

Positioning is a critical non-pharmacological intervention factor influencing perioperative respiratory function in patients undergoing painless gastroscopy and colonoscopy. Different positions alter thoracic compliance, airway patency, and diaphragmatic position, thereby affecting the patient's ventilation and oxygenation status. Currently, the standard lateral decubitus position is routinely used for painless gastroscopy and colonoscopy, and it has been demonstrated to reduce the incidence of hypoxemia. However, this position presents challenges such as difficulties in patient monitoring and localized pressure-related discomfort. In contrast, the supine head-up and lateral decubitus head-up positions, by elevating the head and adjusting the body angle, effectively mitigate tongue base prolapse and improve thoracic expansion, theoretically reducing the risk of hypoxemia. Nevertheless, there is currently a lack of multicenter, large-sample, prospective randomized controlled studies to compare the efficacy and safety of these three positions in preventing hypoxemia in recovery rooms for painless gastroscopy and colonoscopy patients. Consequently, there is no unified evidence-based guideline for selecting the optimal clinical positioning.

Based on this, this study focuses on three clinically common positions and employs a multicenter, three-arm, randomized controlled parallel design to systematically investigate the effects of lateral supine with head elevated, supine with head elevated, and standard lateral position on postoperative hypoxemia in patients undergoing painless gastroscopy and colonoscopy. The aim is to fill a research gap in this field and provide high-quality evidence-based medical data to optimize postoperative position management during recovery and reduce adverse respiratory events following painless gastrointestinal endoscopy.

Special Note:Prespecified subgroup analyses will be conducted based on age (<65 vs ≥65), sex, BMI, ASA class, smoking and alcohol use, Mallampati score, anesthetic agent (clobupol or propofol), type of endoscopy (gastroscopy, colonoscopy, or gastroenteroscopy), Ramsay sedation score (2-4), pre-procedure hypoxemia, prior pulmonary surgery, OSA, respiratory disease, and intra-procedural hypoxemia (SpO₂ ≤90% for >10 seconds). The influence of heterogeneity on the primary outcome will also be evaluated.

Being tested
lateral decubitus head-up position (LH group), supine head-up position (SH group), standard lateral decubitus position group (SL group)

What participants receive

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

  • lateral decubitus head-up position (LH group)Procedure or surgery

    An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response. Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score. Prior to enrollment, all patients remain in the left lateral position (bed head elevated 0°, consistent with the examination position). Patients assigned to the lateral supine head-elevated group (LH group) maintain their pre-assigned lateral position with the head elevated 30°.

  • supine head-up position (SH group)Procedure or surgery

    An angle measuring device is placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale score is assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to tactile or pain stimuli; 5 = asleep but slow to tactile or pain responses; 6 = deep sleep with no response. Patients scoring 2-4 are immediately randomized into the study group, while those below this range are randomized after achieving the required score. All patients are initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination). Patients assigned to the supine head-elevated group (SH group) are transitioned from the lateral position to supine without a headrest, with the head elevated at 30°.

  • standard lateral decubitus position group (SL group)Procedure or surgery

    An angle measuring device was placed beside the head of the examination bed to facilitate precise adjustment of the head position. Upon admission to the recovery room, the patient's Ramsay Sedation Scale was assessed by an independent investigator (the attending anesthesiologist): 1 = agitated; 2 = fully awake, calm and cooperative; 3 = drowsy but responsive to verbal commands; 4 = drowsy but responsive to touch or pain; 5 = asleep but slow to respond to touch or pain; 6 = deep sleep with no response. Patients scoring 2-4 were immediately randomized into the study group, while those below this range were randomized after achieving the required score. All patients were initially positioned in the left lateral decubitus position (head elevated at 0°, the same as during examination). Patients in the Standard Lateral Position Group (SL group) maintained their original left lateral position with the head elevated at 0°.

Study groups in NCT07587970
Study groupRoleWhat they receive
lateral decubitus head-up position group (LH group)ExperimentalThe patient maintains the predetermined lateral position with the head of the bed elevated at 30 degrees.
Receives: Procedure: supine head-up position (SH group); Procedure: standard lateral decubitus position group (SL group)
supine head-up position group (SH group)ExperimentalThe patient was transferred from a pre-existing lateral decubitus position to a supine position without a headrest, with the head of the bed elevated at 30 degrees.
Receives: Procedure: lateral decubitus head-up position (LH group); Procedure: standard lateral decubitus position group (SL group)
standard lateral decubitus position group (SL group)ExperimentalPatients should maintain their original left lateral position with the head of the bed elevated at 0 degrees.
Receives: Procedure: lateral decubitus head-up position (LH group); Procedure: supine head-up position (SH group)

What is being measured

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

  1. Incidence of recovery-phase hypoxemia

    Proportion of participants experiencing hypoxemia (SpO₂ ≤ 90% lasting >10 seconds) during the post-procedure recovery period

    Measured: From PACU admission until discharge, assessed up to 30 minutes

Secondary outcomes (11)
  1. Incidence of Subclinical Respiratory Depression during Recovery

    Proportion of participants experiencing subclinical respiratory depression, defined as any episode of pulse oxygen saturation (SpO₂) in the range of 90% to <95% (inclusive of 90%, exclusive of 95%) during the post-procedure recovery period

    Measured: From PACU admission until discharge, assessed up to 30 minutes.

  2. Overall Incidence of Airway Intervention During Recovery

    Proportion of participants requiring any grade of airway intervention (increase oxygen flow, chin lift, mask ventilation, or reintubation) during recovery.

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  3. Cough Severity Grade During Recovery

    Severity of cough assessed during the recovery period, graded as: Grade I: No cough, smooth breathing; Grade II: Single mild cough; Grade III: Multiple coughs lasting <15 seconds; Grade IV: Continuous coughing lasting ≥15 seconds. Reported as the proportion of participants reaching each grade (I-IV).

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  4. Length of Stay in Post-Anesthesia Care Unit (PACU)

    Time from admission to the post-anesthesia care unit (PACU) until discharge criteria are met (modified Aldrete score ≥9 on three consecutive assessments), recorded in minutes.

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  5. Respiratory Comfort Score During Recovery

    Patient-reported respiratory comfort assessed using a Numerical Rating Scale (NRS) ranging from 0 (worst discomfort) to 10 (greatest comfort)

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  6. PACU Nurse Satisfaction Score

    Nurse-assessed satisfaction with patient respiratory stability and overall recovery management, rated using a Numerical Rating Scale (NRS) ranging from 0 (lowest satisfaction) to 10 (highest satisfaction), recorded at patient discharge from the post-anesthesia care unit

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  7. Incidence of Tachycardia During Recovery

    Proportion of participants experiencing tachycardia (heart rate >100 beats/min) during the post-procedure recovery period.

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  8. Incidence of Bradycardia During Recovery

    Proportion of participants experiencing bradycardia (heart rate <50 beats/min) during recovery.

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  9. Incidence of Hypotension During Recovery

    Proportion of participants experiencing hypotension (systolic blood pressure <80 mmHg) during recovery.

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  10. Incidence of Nausea or Vomiting During Recovery

    Proportion of participants experiencing nausea (subjective complaint) or vomiting (objective expulsion of gastric contents) during recovery.

    Measured: From PACU admission until discharge, assessed up to 30 minutes

  11. Incidence of Laryngospasm During Recovery

    Proportion of participants experiencing laryngospasm (acute upper airway obstruction with stridor/inability to ventilate, resolving with intervention) during recovery.

    Measured: From PACU admission until discharge, assessed up to 30 minutes

Timeline

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

  1. First posted14 May 2026
  2. Study start8 May 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,617 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587970
Sponsor's protocol ID
dywe0002
Status last verified
May 2026
First submitted
1 May 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing lateral decubitus head-up position (LH group), supine head-up position (SH group) and standard lateral decubitus position group (SL group) in people with Postoperative Hypoxemia, run by General Hospital of Ningxia Medical 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 6 inclusion and 6 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 17 Jun 2026. 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?

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 xiaoyong wei, Master's degree (86-951-674-3252, weixy9912@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of recovery-phase hypoxemia (time frame: From PACU admission until discharge, assessed up to 30 minutes). 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 17 Jun 2026.

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