NCT04150276

Brief Summary

A study on overweight patients undergoing anesthesia for laparoscopic surgery. \- evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure during awakening on oxygenation in the early postoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration 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

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
29 days until next milestone

Study Start

First participant enrolled

December 3, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

October 31, 2019

Last Update Submit

January 25, 2023

Conditions

Oxygenation

Keywords

OxygenationPositive end-expiratory pressureGeneral anaesthesiaObesityAtelectasisMechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Change in oxygenation

    Arterial blood samples will be collected for measurement of arterial oxygen partial pressure.

    Bloodgases will be obtained 5 minutes before the start of the awakening procedure and 30 minutes after awakening and extubation.

Secondary Outcomes (1)

  • Need for postoperative supplemental oxygen

    First 3 hours postoperatively.

Study Arms (2)

ZEEP during awakening

ACTIVE COMPARATOR

ZEEP will be used during emergence preoxygenation and awakening.

Procedure: ZEEP during awakening

PEEP during awakening

ACTIVE COMPARATOR

PEEP is maintained throughout emergence preoxygenation and awakening.

Procedure: PEEP during awakening

Interventions

ZEEP during awakeningPROCEDURE

ZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening.

ZEEP during awakening
PEEP during awakeningPROCEDURE

PEEP will be maintained throughout emergence preoxygenation and awakening.

PEEP during awakening

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese patients scheduled for elective laparocopic surgery.
  • American Society of Anesthesiologists functional class I-III
  • Body Mass Index 35-50 kg/m2

You may not qualify if:

  • Body Mass Index ≥50 kg/m2
  • Peripheral oxygen saturation (SpO2) breathing air \<94 %
  • Symtomatic asthma, COPD or heart failure
  • Ischemic heart disease
  • Hemoglobin \< 100g/l
  • Smokers and ex-smokers that stopped smoking \< 9 months ago
  • Need for peroperative RM and PEEP higher than in study protocol, as indicated by SpO2 \<92% despite the stipulated FiO2 0.30-0.35.
  • Obstructive sleep apnea syndrome on home-CPAP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Anaesthesia and Intensive Care

Västerås, Region Västmanland, Sweden

Location

Related Publications (1)

  • Ostberg E, Larsson A, Wagner P, Eriksson S, Edmark L. Positive end-expiratory pressure and emergence preoxygenation after bariatric surgery: effect on postoperative oxygenation: A randomised controlled trial. Eur J Anaesthesiol. 2025 Jan 1;42(1):54-63. doi: 10.1097/EJA.0000000000002071. Epub 2024 Oct 3.

    PMID: 39325031DERIVED

MeSH Terms

Conditions

ObesityPulmonary Atelectasis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Erland Östberg, MD, PhD

    Region Västmanland

    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
Consultant, principal investigator

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

December 3, 2019

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Please email request to the study principal investigator.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available after publication of study results, approximately 18 months after study completion.
Access Criteria
Data access requests will be reviewed by a review panel at the Center for Clinical Research, Västerås. Requestors will be required to sign a data acess agreement.

Locations

SE(1)