Postoperative Hypoxemia in Obese Patients

NCT06589011 | Completed DMC

• 2 other identifiers: PT(735)(FWA#000010609)
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative atelectasis can cause postoperative hypoxia which might be avoided by applying pressure support during extubation of obese patients undergoing bariatric surgeries.

Conditions

Atelectasis, Postoperative Pulmonary; Bariatric Surgery

Keywords

pressure support; postoperative atelectasis; obese patients; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• arterial Pao2

  Arterial blood sample was with drawn from the patients on room air after extubation

  immediately after arrival to the PACU within 10 minutes after extubation.

Secondary Outcomes (2)

• Postoperative atelectasis

  30 minutes after arrival to the PACU

• respiratory rescue measures

  within 48 hours postoperatively

Study Arms (2)

Pressure support

ACTIVE COMPARATOR

The initial pressure support ventilation setting was a driving pressure of 7 cm H2O, PEEP of 5 cm H2O, and safety backup ventilation of 12 breaths/min (safety backup ventilation setting, VT, 8 ml/kg of predicted body weight; and PEEP, 5 cm H2O). The flow trigger and end of breath were set at 2 l/min and 30% of peak flow, respectively.

Other: Pressure Support Ventilation

control group

PLACEBO COMPARATOR

The emergence process was led by the discretion of the attending anesthesiologist. The basic strategy was to allow the patient to breathe spontaneously and only help respiration if necessary, with intermittent manual assistance.

Other: spontaneously assisted breathing

Interventions

Pressure Support Ventilation OTHER

The initial pressure support ventilation setting was a driving pressure of 7 cm H2O, PEEP of 5 cm H2O, and safety backup ventilation of 12 breaths/min

Pressure support

spontaneously assisted breathing OTHER

The basic strategy was to allow the patient to breathe spontaneously and only help respiration if necessary, with intermittent manual assistance.

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-III patients.
• aged from 18-60 years old.
• body mass index :(BMI) ≥ 35 Kg/m2 scheduled for laparoscopic bariatric surgery.

You may not qualify if:

• age ≤18 or ≥ 60 years.
• pregnant females.
• underlying lung pathology, moderate to severe impairment of RFT, previous lung surgery, pneumothorax and pleural effusion.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research institute

Giza, Cairo Governorate, +020, Egypt

Location

Related Publications (3)

• Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.

  PMID: 31587835 BACKGROUND

• van Kaam AH, Lachmann RA, Herting E, De Jaegere A, van Iwaarden F, Noorduyn LA, Kok JH, Haitsma JJ, Lachmann B. Reducing atelectasis attenuates bacterial growth and translocation in experimental pneumonia. Am J Respir Crit Care Med. 2004 May 1;169(9):1046-53. doi: 10.1164/rccm.200312-1779OC. Epub 2004 Feb 20.

  PMID: 14977624 BACKGROUND

• Jeong H, Tanatporn P, Ahn HJ, Yang M, Kim JA, Yeo H, Kim W. Pressure Support versus Spontaneous Ventilation during Anesthetic Emergence-Effect on Postoperative Atelectasis: A Randomized Controlled Trial. Anesthesiology. 2021 Dec 1;135(6):1004-1014. doi: 10.1097/ALN.0000000000003997.

  PMID: 34610099 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Moshira Sayed Lecturer of anesthesia and intensive care, M.D.

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care medicine

Model Details: pressure support versus spontaneous assisted ventilation during extubation from bariatric surgeries.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)