UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057320 |
|---|---|
| Receipt number | R000065416 |
| Scientific Title | Variability of driving pressure with tidal volume delivered by predicted vs ideal body weight in class 1 obesity patient: a pilot randomized clinical trial |
| Date of disclosure of the study information | 2025/03/25 |
| Last modified on | 2026/04/25 02:52:23 |
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Basic information
Public title
Variability of driving pressure with tidal volume delivered by predicted vs ideal body weight in class 1 obesity patient: a pilot randomized clinical trial
Acronym
DP-PIO
Scientific Title
Variability of driving pressure with tidal volume delivered by predicted vs ideal body weight in class 1 obesity patient: a pilot randomized clinical trial
Scientific Title:Acronym
DP-PIO
Region
| North America |
Condition
Condition
Obesity class 1 undergoing head and neck surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing driving pressure with tidal volume using ideal vs predicted body weight in class 1 obesity patient undergoing head and neck surgery
Basic objectives2
Others
Basic objectives -Others
1.- Comparing peak pressure with tidal volume using ideal vs predicted body weight in class 1 obesity patient undergoing head and neck surgery
2.- Comparing plateau pressure with tidal volume using ideal vs predicted body weight in class 1 obesity patient undergoing head and neck surgery
3.- Comparing static compliance with tidal volume using ideal vs predicted body weight in class 1 obesity patient undergoing head and neck surgery
4.- Comparing mechanical power with tidal volume using ideal vs predicted body weight in class 1 obesity patient undergoing head and neck surgery
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine whether there is a difference in driving pressure between tidal volume groups calculated based on predicted body weight vs ideal body weight, measured every 10 minutes during the first hour of head and neck surgery in class 1 obese patients.
Key secondary outcomes
1.- Comparison of peak pressure between tidal volumes calculated using ideal vs predicted body weight in class 1 obese patients undergoing head and neck surgery
2.- Comparison of plateau pressure between tidal volumes calculated using ideal vs predicted body weight in class 1 obese patients undergoing head and neck surgery
3.- Comparison of static compliance between tidal volumes calculated using ideal vs predicted body weight in class 1 obese patients undergoing head and neck surgery
4- Comparison of mechanical power between tidal volumes calculated using ideal vs predicted body weight in class 1 obese patients undergoing head and neck surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tidal volume calculated using predicted body weight (PBW)
Patients in this group will receive mechanical ventilation with tidal volume calculated based on predicted body weight (PBW) according to the ARDSNet formula. The mechanical ventilation parameters, including driving pressure, plateau pressure, peak pressure, static compliance, dynamic compliance, and transairway pressure, will be recorded every 10 minutes during the first hour of head and neck surgery
Interventions/Control_2
Tidal volume calculated using ideal body weight (IBW)
Patients in this group will receive mechanical ventilation with tidal volume calculated based on ideal body weight (IBW) instead of predicted body weight. The same mechanical ventilation parameters (driving pressure, plateau pressure, static compliance will be recorded at the same time points as in the intervention group.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.- Adult patients (>18 years old) of both sexes.
2.- Rightful beneficiaries (derechohabientes) of the Instituto Mexicano del Seguro Social (IMSS).
3.- Body mass index (BMI) >30 kg/m2 <35kg/m2 (Class 1 obesity).
4.- Scheduled for elective head and neck surgery.
5.- Indicated for general anesthesia and mechanical ventilation during surgery.
Key exclusion criteria
1.- Patients with a body mass index (BMI) lower than 30 or higher than 35.
2.- Patients with a history of obstructive pulmonary disease: asthma or chronic obstructive pulmonary disease (COPD).
3.- Patients requiring intensive care therapy in the postoperative period.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Diego |
| Middle name | |
| Last name | Escarraman |
Organization
Instituto Mexicano del Seguro Social
Division name
Anesthesiology
Zip code
02990
Address
Paseo de las Jacarandas sin numero, colonia La Raza, Azcapotzalco, Ciudad de Mexico
TEL
+525570778209
diego-piloto@hotmail.com
Public contact
Name of contact person
| 1st name | Yesenia |
| Middle name | Tania |
| Last name | Acosta |
Organization
Instituto Mexicano del Seguro Social
Division name
Anesthesiology
Zip code
02990
Address
Paseo de las Jacarandas sin numero, colonia La Raza, Azcapotzalco, Ciudad de Mexico
TEL
+525561676671
Homepage URL
taniayesen23@gmail.com
Sponsor or person
Institute
Instituto Mexicano del Seguro Social
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Instituto Mexicano del Seguro Social, Hospital de Especialidades La Raza
Address
Paseo de las Jacarandas sin numero, colonia La Raza, Azcapotzalco, Ciudad de Mexico
Tel
+525510489201
miguele.saavedra@imss.gob.mx
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.revcolanest.com.co/index.php/rca/article/view/1194
Publication of results
Published
Result
URL related to results and publications
https://www.revcolanest.com.co/index.php/rca/article/view/1194
Number of participants that the trial has enrolled
30
Results
The predicted body weight group showed higher driving pressure, plateau pressure, and peak pressure, with slightly lower static compliance and mechanical power, although none of these differences were statistically significant. The only significant difference was delivered tidal volume (420 +/- 100 mL vs. 460 +/- 30 mL; p = 0.03).
Results date posted
| 2026 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 20 | Day |
Baseline Characteristics
Of the total sample (N = 30), 76.7% were female, with a median age of 54.5years (IQR 16years). The median Vt was 450mL (63mL). In terms of between-group comparisons, a statistically significant difference was 10 observed only in Vt, PBW 420mL (100 mL) vs IBW 460mL (30 mL); p=0.03.
Participant flow
A total of 39 patients were recruited. Of these, eight were excluded due to a BMI outside the inclusion range ( less 30 or more 35 kg/m2), and one was excluded due to incomplete data, resulting in a final sample of 30 patients
Adverse events
Non
Outcome measures
The primary objective was to compare the variability and trend of driving pressure during the first surgical hour. Secondary outcomes included plateau pressure, peak pressure, static compliance, and mechanical power.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2024 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2026 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065416
