NCT07065370

Brief Summary

To compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries. Primary outcome: Incidence of postoperative hypoxemia within the first 24 hour after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

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

Study Start

First participant enrolled

November 30, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

November 1, 2022

Enrollment Period

Same day

First QC Date

June 26, 2025

Last Update Submit

July 3, 2025

Conditions

Laparoscopic Bariatric SurgeriesHypoxemiaObese Patients

Keywords

mechanical powerhypoxemiamorbid obese patientslaparoscopic bariatric surgeries

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypoxemia

    24 hours postoperative

Secondary Outcomes (1)

  • Correlation between the intraoperative mechanical power and postoperative hypoxemia

    24 hours postoperative

Study Arms (2)

Group I

EXPERIMENTAL

Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.

Device: Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.

Group II

EXPERIMENTAL

Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 18-20 cycle/minute

Device: Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg )

Interventions

Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.DEVICE

Volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.

Group I
Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg )DEVICE

group received volume-controlled ventilation with tidal volume 6-8ml/kg predicted body weight with respiratory rate 18-20 cycle/minute

Group II

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21-60 years
  • American society of anesthesiology physical status III
  • Body mass index ≥ 40 kg/m2 undergoing laparoscopic bariatric surgery.

You may not qualify if:

  • Uncontrolled respiratory morbidity such as sever bronchial asthma or chronic obstructive pulmonary disease.
  • Patients with valvular or ischemic heart diseases, or uncontrolled hypertension
  • Patients with hepatic dysfunction or renal or endocrine disorders,
  • Patients with history of cerebrovascular disease or uncontrolled Diabetes mellitus.
  • Previous lung surgery
  • Pregnant
  • Patients with neuromuscular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Tidal Volume

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inspiratory CapacityVital CapacityTotal Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Ahmed Elbradey, Resident

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 15, 2025

Study Start

November 30, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

July 15, 2025

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

EG(1)