Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGeneral Hospital of Ningxia Medical University

About this trial

To investigate the independent effects and interaction of pre-oxygenation position (left lateral vs left lateral with 30° head-up tilt) and examination position (left lateral vs left lateral with 30° head-up tilt) on hypoxemia during painless gastroscopy and colonoscopy using a 2×2 factorial design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years, regardless of gender

Body mass index (BMI): 18.5 - 35 kg/m²

ASA physical status class I, II or III

Scheduled for painless gastroscopy, painless colonoscopy, or combined painless gastroenteroscopy

Disqualifiers

Severe cardiopulmonary diseases, including severe COPD, heart failure, severe arrhythmia and pulmonary hypertension

Difficult airway identified before anesthesia

Severe obstructive sleep apnea (OSA)

Spinal or thoracic deformity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pre-oxygenation Position (left lateral position)

    Procedure/Surgery

    An angle measuring device is placed beside the head of the examination bed to enable precise adjustment of the head position. Pre-oxygenation phase: Administer pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; instruct the patient to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout. If the position is altered during this phase, discontinue the procedure. Left lateral pre-oxygenation: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 0°, supported by pillows to maintain a neutral spine position and avoid excessive neck extension or flexion.

  • Examination Position(left lateral position )

    Procedure/Surgery

    Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase. If the position is altered midway through the examination, the patient will be excluded from the study. Left lateral position examination: The patient assumes a 90-degree left lateral position on a horizontal bed surface with the head of the bed elevated to 0°, supported by pillows to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.

  • Pre-oxygenation Position( left lateral head elevation in a 30-degree position)

    Procedure/Surgery

    An angle measuring device is placed beside the head of the examination bed to allow precise adjustment of the head position. Pre-oxygenation phase: The patient receives pure oxygen via a standardized mask with tight fit, at a flow rate of 6 L/min; they are instructed to take deep breaths while receiving continuous oxygen for 3 minutes, maintaining the same body position throughout. If the position is altered during this phase, the procedure is discontinued. Left-sided head elevation (30°): During pre-oxygenation, the patient lies in a left lateral position on a horizontal bed surface with the head elevated by 30°, supported by pillows to maintain a neutral spinal alignment and prevent excessive neck extension or flexion.

  • Examination Position(left lateral head elevation in a 30-degree position)

    Procedure/Surgery

    Examination Phase: From the initiation of anesthesia and endoscope insertion until completion of the procedure, the patient's position and head-of-bed angle must remain fixed throughout; any adjustments are prohibited during this phase. If the position is altered midway through the examination, the patient will be excluded from the study. Left lateral decubitus examination: The patient assumes a left lateral position on a horizontal bed surface with the head elevated at 30°, supported by a pillow to maintain a neutral spinal alignment, avoiding excessive neck extension or flexion.

Treatment groups

208 Participants
are divided into 4 treatment groups
Group A: Group A1B1 (traditional conventional group)Active comparator 2 interventions
Group B: Group A1B2 (improved examination group)Experimental treatment 2 interventions
Group C: Group A2B1 (pre-oxygenation improvement group)Experimental treatment 2 interventions
Group D: Group A2B2 (double-position improvement group)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of hypoxemia

Incidence of SpO₂ ≤ 90% for \>10 seconds during the examination.

Time frame
During procedure

Secondary outcomes

1

Safe duration of pre-oxygenation

Time from cessation of oxygen administration (start of anesthesia induction) to first SpO₂ \<92% for ≥3 seconds. If no desaturation occurs, the value equals the duration from oxygen cessation to end of procedure (right-censored).

Time frame
During procedure
2

Incidence of subclinical respiratory depression

Defined as the proportion of participants experiencing SpO₂ between 90% and 95% (inclusive) at any time during the examination.

Time frame
During procedure
3

Requirement for jaw thrust

Number of participants requiring manual jaw thrust to relieve airway obstruction during the examination.

Time frame
During procedure
4

Requirement for nasal cannula oxygen

Number of participants requiring oxygen supplementation via nasal cannula during the examination.

Time frame
During procedure

Other outcomes

1

Safety outcome endpoints:heart rate

Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal).

Time frame
Baseline and during procedure
2

Safety outcome endpoints:blood pressure

Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal)

Time frame
Baseline and during procedure
3

Safety outcome endpoints:peripheral oxygen saturation (SpO₂)

Recorded at T0 (before pre-oxygenation), T1 (before induction), T2 (scope insertion), and T3 (scope removal).

Time frame
Baseline and during procedure
4

Safety outcome endpoints:Incidence of hemodynamic instability in recovery

Occurrence of tachycardia (\>100 bpm), bradycardia (\<50 bpm), or hypotension (systolic blood pressure \<80 mmHg) during the recovery period.

Time frame
Up to 30 minutes post-anesthesia care unit (PACU) admission

Sponsors and contacts

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