NCT06247943

Brief Summary

Obesity is becoming a common condition and bariatric metabolic surgery is one of the main options for treating morbid obesity. However, since most patients undergoing robotic bariatric surgery are class III obese, it brings new challenges to perioperative anesthesia management. Here, we explored the effects of lung-protective ventilation strategies on pulmonary oxygenation function and respiratory mechanics in patients undergoing robotic bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

December 25, 2023

Last Update Submit

March 19, 2024

Conditions

Respiration

Outcome Measures

Primary Outcomes (5)

  • Respiratory mechanics

    plateau airway pressure

    5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

  • oxygenation

    Oxygenation index

    5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

  • oxygenation

    arterial oxygen partial pressure

    5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

  • Respiratory mechanics

    peak airway pressure

    5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

  • Respiratory mechanics

    end-tidal carbon dioxide partial pressure

    5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

Secondary Outcomes (2)

  • Hemodynamics

    5 minutes after tracheal intubation (T0), 10 minutes after the start of pneumoperitoneum (T1), 60 minutes (T2), 120 minutes (T3), and 10 minutes after the closure of the pneumoperitoneum (T4)

  • complications

    postoperative days 1, 3, and 5

Study Arms (2)

Lung Protective Ventilation Strategy Group

EXPERIMENTAL

Use of lung-protective ventilation strategies

Procedure: Lung Protective Ventilation Strategy

Control Group

OTHER

Use of general ventilation strategies

Procedure: regular ventilation

Interventions

Lung Protective Ventilation StrategyPROCEDURE

After 10 minutes of pneumoperitoneum, VT 7 ml/kg was used, PEEP 6 cmH2O, FiO2 was 40%, and plateau pressure \<30 cmH2O was maintained throughout.

Lung Protective Ventilation Strategy Group
regular ventilationPROCEDURE

VT 9ml /kg without PEEP, FiO2 of 60%

Control Group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Obese patients with ASA grade Ⅰ \~ Ⅲ No obvious abnormality in preoperative lung function and blood gas analysis results Undergoing robotic bariatric surgery

You may not qualify if:

  • Had been mechanically ventilated 2 weeks before surgery Thoracic deformity Neuromuscular disease Significant abnormalities in vital organ function Combined pneumothorax or pulmonary herniation Participating in other clinical intervention trials or refusing general anesthesia with tracheal intubation Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 25, 2023

First Posted

February 8, 2024

Study Start

January 1, 2024

Primary Completion

March 16, 2024

Study Completion

March 17, 2024

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

CN(1)